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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 Problems Stroke/CVA (1770); Paralysis (1997); No Code Available (3191)
Event Type  Injury  
Event Description
Stroke [stroke], completely paralyzed on his right side [right sided paralysis], nonverbal [speech loss], injured/reason for him getting synvisc-one injections [device use in unapproved indication]. Case narrative: this case is cross referenced with case id: (b)(4) (multiple devices) and (b)(4) (cluster case). Initial information received on 12-mar-2019 from united states regarding an unsolicited valid serious case received from patient's wife. This case involves a (b)(6) male patient who experienced stroke, completely paralyzed on his right side, nonverbal and injured/reason for him getting synvisc-one injections, while he using with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one). (latency: unknown). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On (b)(6) 2017, the patient took hylan g-f 20, sodium hyaluronate injection at dosage of 6 ml for once only in 6 months unknown (lot - unk) for injury. On the unknown date, after six weeks of injection, patient developed stroke. It was also reported that he completely paralyzed on his right side and nonverbal. It was also reported that he was injured on duty and was given synvisc one injections. Final diagnosis was injured/reason for him getting synvisc-one injections, nonverbal, completely paralyzed on his right side and stroke. Corrective treatment: not reported for all the events. Outcome: unknown for rest of the events. Seriousness criteria: medically significant for stroke and completely paralyzed on his right side. 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
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key8431907
MDR Text Key139182390
Report Number2246315-2019-00084
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,Followup
Report Date 11/01/2019
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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