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

Lot Number UNKNOWN

Device Problem No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Event Description

Unable to wak [walking difficulty] ([muscle contracture], [pain legs]). Chest infection [chest infection]. Case narrative: initial information received on 04-jun-2018 from (b)(6) regarding an unsolicited valid serious case received from a consumer. This case involves an unknown age female patient who was unable to walk (latency: few days) and developed a chest infection (latency: unknown), after receiving an injection of synvisc-one. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an intra-articular synvisc-one injection, dose 6 ml (indication and batch number: unknown). On an unknown date after receiving the injection, the patient reported that she was unable to walk (latency: few days) and experienced the same for at least one week. After receiving the injection, patient reported that she had an adverse reaction to synvisc-one and reported muscles in both legs from knee down contracted and she ended up in a wheelchair. Further, it was reported that the patient suffered tremendous pain in both legs from end of (b)(6). On an unknown date after receiving the injection, patient developed chest infection (latency: unknown). The patient states that the doctor never said there would be a reaction. She also stated that, she is upset as her trip had to postponed as she developed a chest infection while on the journey. Corrective treatment: wheelchair for unable to walk. Seriousness criterion: disability for unable to walk, medically significant for chest infection. Outcome: unknown both events. A product technical complaint was initiated on 07-jun-2018 for synvisc one, 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 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 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 adverse events to determine if a capa is required. Additional information was received on 07-jun-2018. Ptc results were added. Upon internal review 07-jun-2018 eu/ca form was updated and mir form was attached in the case and.

• 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: 7919587
• MDR Text Key: 122150350
• Report Number: 2246315-2018-00607
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes

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: 09/28/2018 Patient Sequence Number: 1