MAUDE Adverse Event Report: SOLEVA PHARMA LLC MUGARD; DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC

Lot Number MV1038

Patient Problem Insufficient Information (4580)

Event Date 06/18/2023

Event Type  Death  

Event Description

Pt passed away.Add'l info: use-5-10ml in the mouth 4-6 times daily may swish and /or swallow.

• Brand Name: MUGARD
• Type of Device: DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
• Manufacturer (Section D): SOLEVA PHARMA LLC
• MDR Report Key: 17424677
• MDR Text Key: 320127620
• Report Number: MW5120337
• Device Sequence Number: 1
• Product Code: MGQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: MV1038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Sex: Female