MAUDE Adverse Event Report: FERRING EUFLEXXA; INJECTION

Device Problem Overheating of Device (1437)

Patient Problem Sweating (2444)

Event Date 01/19/2016

Event Type  Injury  

Event Description

After my 2nd and 3rd euflexxa injections (they are given in a series of 3 injections, 1 week apart), within a half-hour of the injection, i became severely overheated and sweating all over my body for a couple of hours.About an hour or so after the injection, my heart began to race excessively and continue to do so for several hours thereafter.After about 16 hours or so, these symptoms completely resolved themselves.Dates of use: (b)(6) 2016.Reason for use: osteoarthritis of the knee.

• Brand Name: EUFLEXXA
• Type of Device: INJECTION
• Manufacturer (Section D): FERRING
• MDR Report Key: 5393994
• MDR Text Key: 36972471
• Report Number: MW5059645
• 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: 01/20/2016

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: 01/20/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 111