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

Lot Number 082811

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/31/2020

Event Type  Injury  

Event Description

Hospitalization.

• Brand Name: GELCLAIR GEL PAP
• Type of Device: DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
• Manufacturer (Section D): MIDATECH PHARMA US / HELSINN HEALTHCARE SA
• MDR Report Key: 10483251
• MDR Text Key: 205514217
• Report Number: MW5096390
• Device Sequence Number: 1
• Product Code: MGQ
• UDI-Device Identifier: 89141045602
• UDI-Public: 89141-0456-02
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 082811
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 91