MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-20 for GELCLAIR GEL PAP manufactured by Unk.
[167561390]
Pt deceased.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5091205 |
| MDR Report Key | 9353927 |
| Date Received | 2019-11-20 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-11-18 |
| Date Added to Maude | 2019-11-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GELCLAIR GEL PAP |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2019-11-20 |
| Lot Number | 316611 |
| Device Expiration Date | 2019-09-30 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-11-20 |