From: Quality analysis of manufacturer's incident reports regarding medical devices
Field | % | |
---|---|---|
Manufacturer information | Name | 98.88 |
84.69 | ||
Country | 97.58 | |
Authorised Representative Information | Name | 91.17 |
90.72 | ||
Submitter’s information | Name | 96.06 |
94.71 | ||
Medical device information | Commercial name brand name/make | 98.10 |
Serial number(s) (if applicable) | 74.65 | |
Lot/batch number(s) (if applicable) | 71.30 | |
Incident Information | Date the incident occurred | 70.50 |
Incident description narrative | 99.13 | |
Manufacturer’s awareness date | 98.70 | |
Medical device current location/disposition (if known) | 66.26 | |
Patient information | Patient outcome | 87.98 |
Healthcare facility information | Name | 83.14 |
43.88 |