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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOVISC INJECTION

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ORTHOVISC INJECTION Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Fatigue (1849); Headache (1880); Unspecified Infection (1930); Pain (1994); Swelling (2091); Chills (2191); Complaint, Ill-Defined (2331); Injury (2348)
Event Date 12/02/2014
Event Type  Injury  
Event Description
On (b)(6) 2014 caller had a swollen knee and was diagnosed with a knee infection. On (b)(6) 2014 her knee gave up on her and was told she had a torn acl, mcl and meniscus. She had a 3 session therapy of orthovisc injection from (b)(6). Right after the first injection she started to experience adverse reaction of knee pain, swelling, and flu like symptoms, fatigue, chills and headache. She continues to experience pain and revisited her doctor in (b)(6) 2015 and was given a cortisone shot. An mri was done on (b)(6) 2015 and was informed that she needs a debridement. After the debridement another session of orthovisc injection was given from (b)(6) 2014 but these did not stop the pain. She was then advised to get a knee replacement. She contact a specialist for a second opinion and was given the care needed and the pain subsided with no further injections or surgery. Through research on the web she learned about orthovisc injection and the adverse reaction on fda website which the first doctor failed to share with her. Fda should take this device off the market.
 
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Brand NameORTHOVISC INJECTION
Type of DeviceORTHOVISC INJECTION
MDR Report Key5641616
MDR Text Key44895780
Report NumberMW5062162
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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

Patient Treatment Data
Date Received: 05/09/2016 Patient Sequence Number: 1
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