FDA Adverse Event
Death
Summary report: N
GELCLAIR GEL PAP
MDR report key: 9081826
·
Received September 17, 2019
Report
- Report Number
- MW5089840
- Event Type
- Death
- Date Received
- September 17, 2019
- Report Date
- September 16, 2019
- Manufacturer
- HELSINN HEALTHCARE SA
- Product Code
- MGQ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PT PASSED AWAY. DOSE OR AMOUNT: 15 ML MILLILITRE(S), ORAL - 3 TIMES A DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 872505 | GELCLAIR GEL PAP | DRESSING, WOUND AND BURN, HYDROGEL W/ DRUG AND /OR BIOLOGIC GENERAL & PLASTIC SU | MGQ | HELSINN HEALTHCARE SA | 355611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Death |