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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME SYNVISC ONE INJ 8MG/ML

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GENZYME SYNVISC ONE INJ 8MG/ML Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Swelling (2091); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)
Event Date 03/08/2018
Event Type  Injury  
Event Description
Patient reported experiencing swelling in her right knee which caused her immobility, and she needed physical therapy and acupuncture to treat. She stated that it worsened her osteoarthritis and increased her pain. Lot number and expiration dates unknown at this time, but the pharmacy is investigating.
 
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Brand NameSYNVISC ONE INJ 8MG/ML
Type of DeviceSYNVISC ONE INJ 8MG/ML
Manufacturer (Section D)
GENZYME
MDR Report Key7330472
MDR Text Key102197359
Report NumberMW5075804
Device Sequence Number1
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 Pharmacist
Type of Report Initial
Report Date 03/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2018
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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