CUSTOMER COMPLAINT INFORMATION: IMPLANT

CUSTOMER COMPLAINT INFORMATION- IMPLANT
Customer Contact details
Complaint country of origin*

Street Address

Street Address Line 2

CityState / Province

Postal / Zip CodeCountry
Complaint Reporter’s Details
Name:*

First NameLast Name
Designation: *
Organization: *
Email*
example@example.com
Phone Number*

Area CodePhone Number
Distributor’s details
Organization Name: *
Address*

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code
Contact Person name: *

First NameLast Name
Designation: *
Email*
example@example.com
Phone Number*

Area CodePhone Number
Healthcare Professional name:*

First NameLast Name
Healthcare Professional email (if available):
example@example.com
Hospital/facility name*
Product details
Product description & Model*
Other*
Product code*
Invoice No*
Invoice date*

DayMonthYear
Date
Batch number*
Quantity involved*
YesNo
Please send after decontamination only
Quantity to return for investigation*
RepairReplacementAdditional DocumentsOther
Replacement part delivery address*

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code
Environment
Below 10 °C10-20°C20-30°C30-35°C35-40°C40-45°C45-50°CAbove 50°C
YesNo
Below 10 °C10-20°C20-30°C30-35°C35-40°C40-45°C45-50°CAbove 50°C
Direct sunlightIndirect sunlight in open areaDirect Indoor lightNone of the above
Complaint details
When did the event occur?*

DayMonthYear
Date
Comprehensive description of the event *
What was the Primary Mode of Failure that was Experienced*
Other*
Procedure Performed/Surgical technique used:*
Indication for which the Product was used/intended to be used*
Other*
Before surgeryDuring surgeryAfter surgeryDemo
SpearTrocarDrill BitSlotted SleeveGuidewireTrocar TipPunchPunch/TapTapGraft SizerFluted ReamerInternal SleeveSuture Passing Sleeve with Meniscal Knot Pusher/CutterReamerForcepsInserterScrewdriverNot applicableOther
YesNo
Patient age in years *
FemaleMaleUnknownNot applicable
Patient body weight in Kg*
No patient impactedSurgery time delayExtended hospitalizationExtended hospitalizationMedical Intensive re-interventionMedication requiredRevision surgerySurgical re-intervention requiredInjury to patient or userDisability or permanent damage to patient or userPatient deathUnknown
Please detail length of delay *
Please mention any one option: 0 to 15 min, 15 to 30 min, 30 min to 1 hr, more than 1 hr
Surgery proceeded without impactSurgery proceeded with other Biotek deviceSurgery proceeded with other company’s devicePatient hospitalisedPatient recovered with medicationSurgery postponedNot applicableUnknown
Other company’s device *
YesNo
Details of revision surgery when were the implants originally implanted? *

DayMonthYear
Date
Details of implants (Make)*
Details of implants (Size)*
YesNo
Please attach *

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CUSTOMER COMPLAINT INFORMATION- IMPLANT

Customer Contact details

Complaint Reporter’s Details

Distributor’s details

Product details

Environment

Complaint details