MAUDE Adverse Event Report: SOLEVA PHARMA LLC. MUGARD 240 ML MILLILITRE(S); DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC

Lot Number MV1038

Patient Problem Insufficient Information (4580)

Event Date 12/27/2023

Event Type  Death  

Event Description

The patient's son reports the patient passed away on (b)(6) 2023.No additional information documented.The following product information reflects the last dispense by alliancerx walgreens pharmacy (delivered december 22, 2023) and was not provided by the primary reporter.

• Brand Name: MUGARD 240 ML MILLILITRE(S)
• Type of Device: DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
• Manufacturer (Section D): SOLEVA PHARMA LLC.
• MDR Report Key: 18573557
• MDR Text Key: 333721960
• Report Number: MW5150659
• 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: 01/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• 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: 81 YR
• Patient Sex: Female