MAUDE Adverse Event Report: US WORLDMEDS / SUNSTAR SUISSE SA/ BMG PHARMA S.P.A. GELX; DRESSING, WOUND AND BURN, HYDROGEL,W/DRUG AND/OR BIOLOGIC

Lot Number 2849

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

Patient Problems Tissue Breakdown (2681); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/04/2021

Event Type  Injury  

Event Description

Patient reports more mouth sores and that he has a white film on his tongue.

• Brand Name: GELX
• Type of Device: DRESSING, WOUND AND BURN, HYDROGEL,W/DRUG AND/OR BIOLOGIC
• Manufacturer (Section D): US WORLDMEDS / SUNSTAR SUISSE SA/ BMG PHARMA S.P.A.
• MDR Report Key: 11131534
• MDR Text Key: 225779009
• Report Number: MW5098708
• Device Sequence Number: 1
• Product Code: MGQ
• UDI-Device Identifier: 27505012090
• UDI-Public: 27505-0120-90
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2022
• Device Lot Number: 2849
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 105