MAUDE Adverse Event Report: ORTHOVISC INJ 15 MG/ML

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2016

Event Type  malfunction  

Event Description

One of the heads of the syringe broke. I received 3 shipped and 1 broke. Diagnosis or reason for use: m17. 9.

• Brand Name: ORTHOVISC INJ 15 MG/ML
• Type of Device: ORTHOVISC INJ 15 MG/ML
• MDR Report Key: 5732871
• MDR Text Key: 47713810
• Report Number: MW5062903
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

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