Reporting Form
(CAPA)
Where the incident occurred?
*
In Malaysia
Outside Malaysia
Where did the incident occurred?
*
Government Hospital/Clinic
Private Hospital/Clinic
Unknown
Others
If others please state where incident occurred
Name of Institution
*
Address
*
Street Address
Street Address Line 2
City
State / Province
Postal / Zip Code
Telephone Number
*
Please enter a valid phone number.
Format: (000) 000-0000.
Fax Number
Please enter a valid phone number.
Format: (000) 000-0000.
Contact Person at Site of Incident
*
First Name
Last Name
MDA Registration Number on Package:
*
Device Name:
*
Brand Name:
*
Batch Number:
*
Lot No:
Expiry Date:
*
-
Month
-
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Report Category:
*
Failure of device effectiveness
Deterioration of device effectiveness
Inadequacy in labelling or IFU
Led to death of a patient, user or other person,
Led to serious deterioration in the state of health of a patient, user or other person
May led to death or serious deterioration in the state of health of a patient, user or other person or could do so were the incident to recur
Serious threat to public health
Date of incident
*
-
Month
-
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Date of establishment aware about the incident:
*
-
Month
-
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Description of incident:
*
Device Operator During Time of Incident:
*
Please Select
Healthcare Professional
Patients
Others
Usage of Device
*
Please Select
Initial Use
Single Use / Disposables
Reuse of Single Use
Reuse of Reusable
Re-serviced / Refurbished
Others
List of other devices involved in the incident (if applicable):
Submit
Should be Empty: