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

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

Patient Problems Muscle Weakness (1967); Numbness (2415)

Event Date 03/13/2020

Event Type  Injury  

Event Description

Weakness and numbness in whole leg [lower extremities weakness of].Weakness and numbness in whole leg [numbness in leg].Case narrative: initial information received on (b)(6) 2020 regarding an unsolicited valid serious case received from united states from a non-health care professional via health authority (reference number: mw5093785).This case involves an adult patient who experienced weakness and numbness in whole leg after unknown latency after using medical device 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, the patient received intra-articular hylan g-f 20, sodium hyaluronate injection (strength: 8mg/ml) (dose, frequency, lot and indication - unknown).In context of covid19 crisis, information on batch number was not requested.On (b)(6) 2020, after unknown latency, patient experienced weakness and numbness in whole leg.The events were considered as medically significant.Action taken: unknown for both events.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for both events.A product technical compliant (ptc) was initiated on (b)(6) 2020 for synvisc one with unknown batch number and 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 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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Investigation complete date: (b)(6) 2020.Additional information was received on 05-may-2020 from healthcare professional.Ptc results were added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 10042545
• MDR Text Key: 191272326
• Report Number: 2246315-2020-00062
• 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: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• 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
• Patient Outcome(s): Other; Required Intervention