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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stroke/CVA (1770)
Event Type  Injury  
Event Description
Stroke [stroke]. Case narrative: this case is cross referenced with case: (b)(4) (cluster case). Initial information received on 12-mar-2019 from united states regarding an unsolicited valid serious case received from a non-healthcare professional this case involves a (b)(6) male patient who experienced stroke, 2 days after, he used the medical device of hylan g-f 20, sodium hyaluronate (synvisc one). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient took hylan g-f 20, sodium hyaluronate injection at unknown dosage unknown frequency via intra-articular route (lot number- unknown) for unknown indication. On the unknown date, patient experienced a stroke after 2 days of injection. Final diagnosis was stroke. Corrective treatment: not reported for stroke. Outcome: unknown for stroke. Seriousness criteria: medically significant for stroke. A product technical complaint was initiated, and results were pending for same.
 
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Brand NameSYNVISC ONE
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
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key8431954
MDR Text Key139182702
Report Number2246315-2019-00094
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
Type of Report Initial,Followup
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2019
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: 03/19/2019 Patient Sequence Number: 1
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