MAUDE Adverse Event Report: ORTHOVISC INJ 15MG/ML; HYALURONIC ACID

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 12/08/2016

Event Type  Injury  

Event Description

Notified recent hospitalization via insurance claims.Pt diagnosis: m17.12 - unilateral primary osteoarthritis left knee.Admitted on (b)(6) 2016, discharged on (b)(6) 2016.

• Brand Name: ORTHOVISC INJ 15MG/ML
• Type of Device: HYALURONIC ACID
• MDR Report Key: 6169305
• MDR Text Key: 62323606
• Report Number: MW5066654
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 59676036001
• UDI-Public: 59676036001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• 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: 64 YR