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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Urticaria (2278)
Event Date 08/03/1998
Event Type  Injury  
Event Description
Hives on buttocks, face, behind ears and on thighs [hives], difficulty breathing [difficulty breathing]. Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case from health authorities of united states under reference mw5097754 via pharmacist this case involves an adult female patient who experienced hives on buttocks, face, behind ears and on thighs and difficulty breathing, while 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 started taking hylan g-f 20, sodium hyaluronate via intra articular route (dose, frequency, formulation and batch number unknown) for unknown indication. On (b)(6) 1998, after unknown latency, patient experienced hives on buttocks, face, behind ears and on thighs (urticaria) and difficulty breathing (dyspnea). These events were assessed as medically significant. It was unknown if the patient experienced any additional symptoms or events. No more information provided. Action taken: unknown for both events. The patient was treated with fexofenadine hydrochloride (allegra) and diphenhydramine hydrochloride (benadryl) for urticaria; not reported for other event. The patient outcome is reported as unknown for both events. Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 09-jan-2021 for product. Batch number; unknown. Device not returned. The product lot number was not provided; therefore, a batch record review was not possible. Based on the lack of information provided, no capa (corrective and preventive action) was required. It was the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result was identified and mitigated through the ncr (non-conformance report) 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 had not indicated any safety issue. Sanofi will continue to monitor adverse events to determine if a capa is required. Final investigation complete date: 22-jan-2021. Follow-up was received on 09-jan-2021 from other healthcare professional. Global ptc number added. No significant information received.
 
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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 Key11257359
MDR Text Key233744442
Report Number2246315-2021-00056
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
Report Date 02/01/2021
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
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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