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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
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Sensation in Eye (1869); Hot Flashes/Flushes (2153); Myalgia (2238); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/19/1999
Event Type  Injury  
Event Description
Scratchy eyes [abnormal sensation in eye]. Myalgias [myalgia]. Flushing [flushing]. Case narrative: this case is linked to case (b)(4) (multiple devices). Initial information received on 08-jan-2021 regarding an unsolicited valid serious case from physician via health authorities of united states under reference mw5097839. This case involves adult patient (gender unknown) who was given hylan g-f 20, sodium hyaluronate (synvisc) and experienced scratchy eyes, flushing, myalgias. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate intra-articular injection (dose, frequency, indication, lot - unknown). Information on the batch number was requested. On (b)(6) 1999, (following injection of knees with hylan g-f 20, sodium hyaluronate), after unknown latency, patient had flushing, scratchy eyes (abnormal sensation in eye), myalgias (myalgia). Events of flushing, scratchy eyes, myalgia were assessed as medically significant. Action taken: unknown for all the events. It was not reported if the patient received a corrective treatment. Outcome: unknown for all the events. A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc; batch number: unknown; global ptc number: (b)(4). The product lot number was not provided; therefore, a batch record review is not possible. Based on the lack of information provided, no capa (corrective and preventive action) is required. It is the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result is identified and mitigated through the ncr (non-conformance) process. Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals. This review has not indicated any safety issue. Sanofi will continue to monitor complaints as stated in sop (b)(4) "product event handling" to determine if a capa is required. Final investigation was completed on 21-jan-2021. Additional information was received on 08-jan-2021 from other healthcare professional. Global ptc number was added. Additional information was received on 08-jan-2021 from a physician. Event- given hylan g-f 20, sodium hyaluronate (synvisc) via intraarticular route for serious injury (product use in unapproved indication) was deleted. Indication was updated from serious injury to unknown. Clinical course was updated. Text was amended accordingly. Additional information was received on 21-jan-2021 from other healthcare professional. Gptc results were received and added. Text was amended accordingly.
 
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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 Key11257833
MDR Text Key229629495
Report Number2246315-2021-00060
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 health professional
Type of Report Initial,Followup
Report Date 06/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
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: 02/01/2021 Patient Sequence Number: 1
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