MAUDE Adverse Event Report: EUFLEXXA INJ 10MG/ML

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 12/19/2016

Event Type  Injury  

Event Description

Allergy with synvisc.

• Brand Name: EUFLEXXA INJ 10MG/ML
• Type of Device: EUFLEXXA INJ 10MG/ML
• MDR Report Key: 6199341
• MDR Text Key: 63195406
• Report Number: MW5066867
• Device Sequence Number: 2
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• 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: 12/19/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR