MAUDE Adverse Event Report: FERRING EUFLEXXA

Lot Number 6309501100

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)

Event Date 03/07/2016

Event Type  Injury  

Event Description

Was given a series of shots to improve my mobility and pain and had to pay a large co-pay and as a result of taking euflexxa i have more pain and can hardly move one of my legs. I work and it has really become a problem for me with the pain and mobility. I have had other treatments and they worked as they were supposed to and had so much more pain control. The euflexxa actually increased my pain.

• Brand Name: EUFLEXXA
• Type of Device: EUFLEXXA
• Manufacturer (Section D): FERRING
• MDR Report Key: 5532287
• MDR Text Key: 41455528
• Report Number: MW5061298
• 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: Patient
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: 6309501100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 03/24/2016 Patient Sequence Number: 1