MAUDE Adverse Event Report: SOLEVA PHARMA LLC MUGARD ORAL RINSE 240ML/BTL; DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC

Lot Number MV1040

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

Patient Problem Insufficient Information (4580)

Event Date 06/07/2023

Event Type  Death  

Event Description

Event: (b)(6) at md office confirmed that the pt passed away on (b)(6) 2023.Gently swish and expel 5ml by mouth for 30-60 seconds or longer 4-6 times daily.Do not eat or drink for 1 hour after use.

• Brand Name: MUGARD ORAL RINSE 240ML/BTL
• Type of Device: DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
• Manufacturer (Section D): SOLEVA PHARMA LLC
• MDR Report Key: 17135810
• MDR Text Key: 317303307
• Report Number: MW5118406
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: MV1040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Sex: Male