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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
Couldnt walk [unable to walk] ([device ineffective]) case narrative: initial information received from (b)(6) on (b)(6) 2021 regarding an unsolicited valid non-serious case received from a patient via social media. This case involves an unknown age patient who could not walk, while he/she was treated with hylan g-f 20, sodium hyaluronate [synvisc]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received treatment with hylan g-f 20, sodium hyaluronate (formulation, dose, route, frequency and batch number unknown) unknown indication. On an unknown date, after unknown latency, patient could not walk for a week (gait inability) and it did not help patient (device ineffective). It was reported that patient was on crutches for a week after using hylan g-f 20, sodium hyaluronate. This event was leading to disability. Action taken: unknown corrective treatment: crutches the patient outcome is reported as unknown.
 
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Brand NameSYNVISC
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key11347464
MDR Text Key232511438
Report Number2246315-2021-00073
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Type of Report Initial,Followup
Report Date 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/19/2021 Patient Sequence Number: 1
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