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

Patient Problem Insufficient Information (4580)

Event Type  Death  

Event Description

Caregiver (b)(6) reported that the pt has passed away on (b)(6) 2023.Swish and expel or swallow 5 to 10 ml 4 to 6 times daily as prescribed for management of oral mucositis.Prescriber contact info: (b)(6).

• 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: 17957361
• MDR Text Key: 325943613
• Report Number: MW5147065
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male