MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC./BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/07/2021

Event Type  Death  

Event Description

Patient's wife informed that patient passed away on (b)(6) 2021.No other details given.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC./BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 11292755
• MDR Text Key: 230942964
• Report Number: MW5099258
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR