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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOVISC INJ 15 MG/ML

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ORTHOVISC INJ 15 MG/ML Back to Search Results
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.
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Type of DeviceORTHOVISC INJ 15 MG/ML
MDR Report Key5732871
MDR Text Key47713810
Report NumberMW5062903
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
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 Received06/14/2016
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