MAUDE Adverse Event Report: EUFLEXXA INJ 10MG/ML ; ACID, HYALURONIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arthritis (1723)

Event Date 12/15/2016

Event Type  Injury  

Event Description

Notified of recent hospitalization via insurance claims.Pt's diagnosis for admission: osteoarthritis of the left knee.(b)(4).

• Brand Name: EUFLEXXA INJ 10MG/ML
• Type of Device: ACID, HYALURONIC
• MDR Report Key: 6188879
• MDR Text Key: 62949563
• Report Number: MW5066812
• Device Sequence Number: 1
• 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: 12/15/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR