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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Swelling (2091); Myalgia (2238)

Event Date 02/11/2004

Event Type  Injury  

Event Description

Swelling of hands and feet [peripheral swelling].Myalgias [myalgia].Rash [rash].Case narrative: initial information received on 14-dec-2020 regarding an unsolicited valid serious case from health authorities of united states under reference mw5097797 via pharmacist.This case involves a patient of unknown demographics who experienced swelling of hands and feet, rash and myalgias, while he/she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included gatifloxacin (tequin); omeprazole (prilosec); ranitidine hydrochloride (zantac); benzonatate (tessalon); hctz; folic acid; estrogens conjugated, medroxyprogesterone acetate (prempro); simvastatin (zocor); paracetamol (tylenol); and valdecoxib (bextra).On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate via intra-articular route (formulation, dose, frequency, batch number unknown) for unknown indication.On (b)(6) 2004, after unknown latency, patient had a swelling of hands and feet (peripheral swelling), rash and myalgias (myalgia) (seriousness criteria: medically significant).Action taken: unknown for all events.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for all events.A product technical complaint (ptc) was initiated on 14-dec-2020 for synvisc (lot unknown) with global ptc number (b)(4).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 is identified and mitigated through the ncr (non-conformance) process.Sanofi global pharmacovigilance and epidemiology would continuously monitor 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 would continue to monitor adverse events to determine if a capa was required.Final investigation was completed on 23-dec-2020.Additional information was received on 23-dec-2020 from other healthcare professional.Ptc results received and processed.Global ptc number was added.

• 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: 11100086
• MDR Text Key: 224596993
• Report Number: 2246315-2020-00194
• 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: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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
• Treatment: BEXTRA [VALDECOXIB] (VALDECOXIB),UNKNOWN; FOLIC ACID (FOLIC ACID),UNKNOWN; HCTZ (HCTZ),UNKNOWN; PREMPRO,UNKNOWN; PRILOSEC [OMEPRAZOLE] (OMEPRAZOLE),UNKNOWN; TEQUIN (GATIFLOXACIN),UNKNOWN; TESSALON (BENZONATATE),UNKNOWN; TYLENOL (PARACETAMOL),UNKNOWN; ZANTAC (RANITIDINE HYDROCHLORIDE),UNKNOWN; ZOCOR (SIMVASTATIN),UNKNOWN
• Patient Outcome(s): Other; Required Intervention