FDA Adverse Event Injury Summary report: N

GELCLAIR GEL PAP

MDR report key: 10483251 · Received September 1, 2020

Report

Report Number
MW5096390
Event Type
Injury
Date Received
September 1, 2020
Date of Event
August 31, 2020
Report Date
August 31, 2020
Manufacturer
MIDATECH PHARMA US / HELSINN HEALTHCARE SA
Product Code
MGQ
UDI-DI
89141045602
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TN, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

HOSPITALIZATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
945272 GELCLAIR GEL PAP DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC MGQ MIDATECH PHARMA US / HELSINN HEALTHCARE SA 082811 89141045602

Patients

Seq Age Sex Outcome Treatment
1 64 YR