Product Complaint Form
Step 1: Reporter information
Reporter name
*
First Name
Last Name
Title/role
*
Company or facility name
*
Email address
*
example@example.com
Phone number
*
-
Country Code
-
Area Code
Phone Number
Location address
Street Address
Street Address Line 2
City
State / Province
Postal / Zip Code
Please Select
Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
The Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bosnia and Herzegovina
Botswana
Brazil
Brunei
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo
Cook Islands
Costa Rica
Cote d'Ivoire
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Democratic Republic of the Congo
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Polynesia
Gabon
The Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
North Korea
South Korea
Kosovo
Kuwait
Kyrgyzstan
Laos
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macau
Macedonia
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Nagorno-Karabakh
Namibia
Nauru
Nepal
Netherlands
Netherlands Antilles
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Turkish Republic of Northern Cyprus
Northern Mariana
Norway
Oman
Pakistan
Palau
Palestine
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn Islands
Poland
Portugal
Puerto Rico
Qatar
Republic of the Congo
Romania
Russia
Rwanda
Saint Barthelemy
Saint Helena
Saint Kitts and Nevis
Saint Lucia
Saint Martin
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
Somaliland
South Africa
South Ossetia
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Svalbard
eSwatini
Sweden
Switzerland
Syria
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Transnistria Pridnestrovie
Trinidad and Tobago
Tristan da Cunha
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States
Uruguay
Uzbekistan
Vanuatu
Vatican City
Venezuela
Vietnam
British Virgin Islands
Isle of Man
US Virgin Islands
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Other
Country
Reporter type (select one):
*
Distributor partner
Healthcare back office or healthcare provider non-user
Healthcare provider and end user
Corza employee
Preferred follow-up contact:
*
Reporter only
Include healthcare provider/user (if different from reporter)
Provide healthcare provider/user contact information:
*
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Product Complaint Form
Step 2: Product & Lot Information
Product name/description
Catalog number (if available)
Order number
*
If not available, please provide any order number, invoice number, or shipment date.
Lot number(s) (as printed on the box)
*
If not available, please provide any order number, invoice number, or shipment date.
Quantity defective (# of pieces)
Enter 0 if not applicable
Quantity defective (# of boxes)
Enter 0 if not applicable
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Product Complaint Form
Step 3: Event Information
When was the defect identified?
During inspection (before use)
Preoperative (product prepared but not yet used)
Intraoperative (during procedure)
Postoperative (after procedure)
Event date
*
-
Month
-
Day
Year
Date
Specialty
Procedure type (if available)
What type of tissue/organ was involved in the procedure?
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Product Complaint Form
Step 4: Product Issue Description
Please indicate the product issue:
Needle issue
Suture issue
Packaging issue
Labeling issue
Other
If other, please describe:
*
Please select what best describes your needle issue:
Needle detached
Needle broke
Needle bent at tip
Needle bent in middle of needle
Needle bent upon opening package
Dull needle at first pass
Dull needle in less than 5 passes
Dull needle after more than 5 passes
Other
If needle broke intraoperatively or postoperatively, please provide additional details and any impact to the patient and/or procedure:
*
If other needle issue, please describe:
*
Please select what best describes your suture issue:
Suture broke
Barbed suture did not hold effectively
Barbed suture was missing or had damaged barbs
Suture difficult to remove from packaging (snagging)
Knotting/handling issue
Other
If suture broke intraoperatively or postoperatively, please provide additional details and any impact to the patient and/or procedure:
*
If other suture issue, please describe:
*
Please select what best describes your packaging issue:
Needle or suture not properly seated in packaging
Broken seal
Tray or pouch damage
Missing components
Mislabeled product
Other
If other packaging issue, please describe:
*
As experienced or recounted, please describe the issue in as much detail as possible:
*
Was the sales representative present during the incident?
Yes
No
Was the product used for its intended purpose?
Yes
No
Was the end-user a new user of this product?
Yes
No
Has there been training on the use of the device?
Yes
No
Was a patient involved?
Yes
No
Did the incident result in any of the following?
*
No patient impact
Delay in procedure
Additional suture required
Patient injury or complication
Describe the patient injury or complication (no patient identifiers):
*
If available, please upload any images or video to assist with the investigation here. Photos of defect as well as product label are helpful. (No patient identifiers)
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Product Complaint Form
Step 5: Product Return Information
Can the defective product be returned?
Yes
No
Can the remaining product from the same box be returned?
Yes
No
Can Corza pick up the product at your location?
Yes
No, I would prefer to ship the remaining product to Corza
Please provide any pickup or shipping instructions. If location is different from what was entered previously, please provide updated information here.
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Product Complaint Form
Step 7: Response Letter Request
Would you like to receive a formal response letter from Corza?
Yes
No
If yes, should the response be sent to:
Reporter
Healthcare provider/end user
Both
Provide any additional contact information (name, email, address) for delivery of response letter if in addition to what was previously included in this form.
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