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

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

Patient Problems Urticaria (2278); Swelling/ Edema (4577)

Event Date 11/05/1999

Event Type  Injury  

Event Description

Swelling of lips [swelling of lips], hives on his torso [hives].Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case from health authorities of united states under reference mw5097753 via pharmacist.This case involves an adult male patient who experienced hives on his torso and swelling of lips, while he 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 (b)(4) 1999, the patient started treatment with hylan g-f 20, sodium hyaluronate injection via intraarticular route (dose, frequency, indication and batch number unknown).There will be no information available on the batch number of this case.On (b)(4) 1999, same day at night, after receiving hylan g-f 20, sodium hyaluronate injection, patient developed hives on his torso (urticaria) and swelling of lips (lip swelling).These events were assessed as medically significant.Patient got recovered from these events after 1 day on (b)(4) 1999.Action taken: unknown for both events.It was not reported if the patient received a corrective treatment.The patient outcome is reported as recovered / resolved for both events.A product technical complaint (ptc) was initiated 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 rdg-sop-000440 "product event handling" to determine if a capa is required.Final investigation was completed on 22-jan-2021.Follow up information received on 09-jan-2021 from healthcare professional.Global ptc number added.Additional information was received on 22-jan-2021 from other healthcare professional.Gptc results were received and added.Text was amended accordingly.

• 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: 11257595
• MDR Text Key: 233744183
• Report Number: 2246315-2021-00057
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2021
• 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