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.

• 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: 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

• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

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: 03/01/2021 Patient Sequence Number: 1