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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME SYNVISC ONE

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GENZYME SYNVISC ONE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Ambulation Difficulties (2544)
Event Date 06/07/2017
Event Type  Injury  
Event Description
My doctor injected synvisc one into my right knee due to lack of cartilage. After the injection i was barely able to walk for three months. With some concern i elected to have the shot in my left knee and it was ok. I have since found out that there was a problem with the syringe that come with synvisc one and can cause an infection with pain. Date the person stopped taking or using the product: (b)(6) 2017. Did the problem stop after the person reduced the dose or stopped taking or using the product: no. Why was the person using the product: osteoarthritis.
 
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Brand NameSYNVISC ONE
Type of DeviceSYNVISC ONE
Manufacturer (Section D)
GENZYME
MDR Report Key7224591
MDR Text Key98566716
Report NumberMW5074929
Device Sequence Number0
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2018
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
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

Patient Treatment Data
Date Received: 01/26/2018 Patient Sequence Number: 1
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