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

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.

• Brand Name: SYNVISC
• Type of Device: MOZ
• 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 Key: 11257359
• MDR Text Key: 233744442
• Report Number: 2246315-2021-00056
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• 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 Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention