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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME SYNVISC ACID, HYALURONIC, INTRAARTICULAR

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GENZYME SYNVISC ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Edema (1820); Pain (1994); Inadequate Pain Relief (2388); Ambulation Difficulties (2544); Weight Changes (2607)
Event Date 01/04/2018
Event Type  Injury  
Event Description
Patient is experiencing severe pain in both knees after knee injection as well as a ambulation difficulties, loss of appetite and weight loss. She states it's been 3 weeks with no pain relief. Patient went to the emergency room (er) and fluid was drained from her knees, but did not help with pain relief. Patient also received cortisone injections, also with no relief.
 
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Brand NameSYNVISC
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME
unk
MDR Report Key7227958
MDR Text Key98645623
Report NumberMW5074962
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 Patient
Type of Report Initial
Report Date 01/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2018
Is this an Adverse Event Report? Yes
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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