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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOVISC INJ 30MG/2ML ACID, HYALURONIC, INTRAARTICULAR

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ORTHOVISC INJ 30MG/2ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Off-Label Use (1494)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2019
Event Type  Injury  
Event Description
Pt is prescribed orthovisc for duration of 6 weeks which is off-label and over recommended duration.
 
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Brand NameORTHOVISC INJ 30MG/2ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
MDR Report Key9519763
MDR Text Key172841344
Report NumberMW5091888
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier59676036001
UDI-Public59676036001
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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