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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME SYNVISC HYLAN GF 20 SYNVISC HYLAN GF 20 2ML

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GENZYME SYNVISC HYLAN GF 20 SYNVISC HYLAN GF 20 2ML Back to Search Results
Lot Number Q1403
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Pain (1994); Inadequate Pain Relief (2388)
Event Date 01/11/2016
Event Type  Injury  
Event Description
Received first synvisc hylan of 20 injection on (b)(6) 2015, had major pain to point where i could not bend or walk on right knee. Missed several days of work. Second injection (b)(6) 2016, similar pain as first but not nearly as bad, 24 hrs after had minimal back pain, 48 hrs back pain was very painful, 72 hrs excruciating electric stabbing pain in lower back to point of screaming and i have high pain tolerance. Contacted (b)(6), he said that the synvisc would not be causing back pain and he had never heard of that happening. Asked if i did anything out of the norm which i answered no. I told him i read about possible side effects before calling. He told me to contact my back doctor which i don't have one. I'm supposed to get third injection on (b)(6) 2016 but now i'm scared to. Frequency: 1 per week for 3 weeks. Route: injected into knee. Reason for use: treating of arthritis in right knee. Event reappeared after reintroduced? yes.
 
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Brand NameSYNVISC HYLAN GF 20
Type of DeviceSYNVISC HYLAN GF 20 2ML
Manufacturer (Section D)
GENZYME
MDR Report Key5367705
MDR Text Key36052783
Report NumberMW5059333
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 01/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2017
Device Lot NumberQ1403
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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