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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE INJ BMG/ML; ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORPORATION SYNVISC ONE INJ BMG/ML; ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Local Reaction (2035); Joint Swelling (2356); Ambulation Difficulties (2544)
Event Date 04/16/2020
Event Type  Injury  
Event Description
Patient reports that has not been able to walk after his injection 5 days ago and had to be taken to his car in a wheelchair.He still can't walk today and complained of large knot on the side of his knee that is warm to the touch with pain that radiates throughout his entire leg.
 
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Brand Name
SYNVISC ONE INJ BMG/ML
Type of Device
ACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key9992311
MDR Text Key188862649
Report NumberMW5094240
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier58468009003
UDI-Public58468009003
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/22/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age92 YR
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