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

Lot Number UNKNOWN

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

Patient Problems Rash (2033); Swelling (2091); Urticaria (2278); No Code Available (3191)

Event Type  Injury  

Event Description

Hives [hives].Swellings of ankles and lips [lip swelling].Respiratory cough [cough].Rash [rash].Swelling of her ankles [ankle swelling].Case narrative: this case is cross referenced with case (b)(4).Initial information received on 09-aug-2018 from united states regarding an unsolicited valid serious case received from a consumer.This case involves a (b)(6) years old female patient who experienced hives, rash, swelling of her ankles, swellings of ankles and lips and respiratory cough after receiving treatment with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date in (b)(6) 2018, the patient received intra-articular injection of synvisc one (hylan g-f 20, sodium hyaluronate) at 6ml 1x (lot number: unknown) for arthritis in both knees.It was reported by the patient's husband that after receiving the injection in (b)(6) 2018, the patient developed hives (latency: unknown), rash (latency: unknown), swelling of her ankles (latency: unknown), swellings of ankles and lips (latency: unknown) and respiratory cough (latency: unknown).The patient previously received synvisc-one injections in (b)(6) 2017 and 0n (b)(6) 2018 and had a similar reaction.It was reported that the same symptoms came back after the (b)(6) 2018 injection and the patient had to be given steroids for them which helped initially however the symptoms were back again.Corrective treatment: steroids.Seriousness criterion: required intervention for all events.Outcome: recovered/resolved for respiratory cough; not recovered for rest of the events.A pharmaceutical technical complaint (ptc) was initiated on 27-aug-2018 for synvisc one 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 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 process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed 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.Additional information was received on 27-aug-2018.Global ptc number and results were added.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 7926299
• MDR Text Key: 122504019
• Report Number: 2246315-2018-00642
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2018

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2018
• 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): Required Intervention