MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 06/25/2022

Event Type  Injury  

Event Description

Euflexxa off-label in the shoulder 1 injection weekly for 3 weeks.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 14854247
• MDR Text Key: 295037892
• Report Number: MW5110565
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• 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?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female