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

Lot Number UNKNOWN

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Must use a walker because she is very handicapped after [walking aid user].Pain for 2-3 days after the injection but the recovery time is getting longer and longer [injection site pain].Patient received synvisc one injection in left hip [product administered at inappropriate site].Case narrative: initial information received on 22-feb-2021 regarding an unsolicited valid serious case received from a patient from (b)(6).This case is cross referred with cases (b)(4), (b)(4) and (b)(4) (multiple devices, same patient).This case involves a (b)(6) years old female patient who received hylan g-f 20, sodium hyaluronate (synvisc one) and must use a walker because she is very handicapped after, pain for 2-3 days after the injection but the recovery time is getting longer and longer, patient received synvisc one injection in left hip.The patient's past medical history, vaccination(s) and family history were not provided.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate injection (second injection), at a dose of 6 ml, once (route and lot - unknown) in left hip (product administered at inappropriate site) for osteoarthritis of the hip.Information on batch number was requested.On the same day, patient only experienced pain for 2-3 days after the injection but the recovery time was getting longer and longer (injection site pain).There was no inflammation, but patient must use a walker because she was very handicapped after (walking aid user, onset date: 2020 and latency: unknown).Patient felt wonderful once she recovered.Patient wanted to know if this was normal, difference between synvisc and synvisc-one, how long were they supposed to last and what was the average recovery time.First time product used: no, still using product: no, was device used : yes.Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for all events.Outcome: recovered for injection site pain and walking aid user, not applicable for other event.Seriousness criteria: disability for walking aid user.A product technical complaint was initiated with results pending for the same.

Event Description

Must use a walker because she is very handicapped after [walking aid user] pain for 2-3 days after the injection but the recovery time is getting longer and longer [injection site pain] patient received synvisc one injection in left hip [product administered at inappropriate site] case narrative: initial information received on 22-feb-2021 regarding an unsolicited valid serious case from a patient from canada.This case is cross referred with (b)(4) (multiple devices, same patient).This case involves a 48 years old female patient who received hylan g-f 20, sodium hyaluronate (synvisc one) and must use a walker because she is very handicapped after, pain for 2-3 days after the injection but the recovery time is getting longer and longer, patient received synvisc one injection in left hip.The patient's past medical history, vaccination(s) and family history were not provided.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate injection (second injection), at a dose of 6 ml, once (route and lot - unknown) in left hip (product administered at inappropriate site) for osteoarthritis of the hip.Information on batch number was requested.On the same day, patient only experienced pain for 2-3 days after the injection but the recovery time was getting longer and longer (injection site pain).There was no inflammation, but patient must use a walker because she was very handicapped after (walking aid user, onset date: 2020 and latency: unknown).Patient felt wonderful once she recovered.Patient wanted to know if this was normal, difference between synvisc and synvisc-one, how long were they supposed to last and what was the average recovery time.First time product used: no, still using product: no, was device used: yes action taken: not applicable for all events it was not reported if the patient received a corrective treatment for all events outcome: recovered for injection site pain and walking aid user, not applicable for other event seriousness criteria: disability for walking aid user a product technical complaint (ptc) was initiated on 22-feb-2021 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 (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 11-mar-2021.Additional information was received on 22-feb-2021 from other healthcare professional.Gptc number was added.Additional information was received on 11-mar-2021 from other healthcare professional.Gptc results were received and added.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11391338
• MDR Text Key: 234023570
• Report Number: 2246315-2021-00080
• 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,health profe
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability