MAUDE Adverse Event Report: FERRING PHARMACEUTICALS EUFLEXXA INJ 10MG/ML ACID HYALURONIC INTRA-ARTICULAR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/01/2017

Event Type  Injury  

Event Description

Patient reported the first time she used euflexxa it worked great for 1 year and the most recent injection was not effective at all.

• Brand Name: EUFLEXXA INJ 10MG/ML
• Type of Device: ACID HYALURONIC INTRA-ARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS
• MDR Report Key: 6529362
• MDR Text Key: 74122077
• Report Number: MW5069376
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 04/27/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage