MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-17 for GELCLAIR GEL PAP manufactured by Helsinn Healthcare Sa.
| Report Number | MW5089840 |
| MDR Report Key | 9081826 |
| Date Received | 2019-09-17 |
| Date of Report | 2019-09-16 |
| Date Added to Maude | 2019-09-18 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GELCLAIR GEL PAP |
| Generic Name | DRESSING, WOUND AND BURN, HYDROGEL W/ DRUG AND /OR BIOLOGIC GENERAL & PLASTIC SU |
| Product Code | MGQ |
| Date Received | 2019-09-17 |
| Lot Number | 355611 |
| Device Expiration Date | 2019-11-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HELSINN HEALTHCARE SA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-09-17 |