MAUDE Adverse Event Report: MIDATECH PHARMA / HELSINN HEALTHCARE SA GELCLAIR GEL (90 PACK); DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC

Lot Number 093811

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/17/2020

Event Type  Death  

Event Description

Patient deceased.

• Brand Name: GELCLAIR GEL (90 PACK)
• Type of Device: DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
• Manufacturer (Section D): MIDATECH PHARMA / HELSINN HEALTHCARE SA
• MDR Report Key: 10867697
• MDR Text Key: 217311286
• Report Number: MW5097964
• Device Sequence Number: 1
• Product Code: MGQ
• UDI-Device Identifier: 89141045603
• UDI-Public: 89141-0456-03
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/28/2021
• Device Lot Number: 093811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 50