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 No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated: 18-nov-2020: this case concerns a patient who was on treatment with synvisc one, and reported to be non-ambulatory for multiple days.The information in the case is limited, hence, the causality for the event cannot be established, however, more information regarding patient's concurrent clinical presentation, relevant medical history, past drugs, concomitant medications, and other risk factors is required for further case assessment.

Event Description

Non-ambulatory for multiple days [gait inability].Case narrative: initial information received from united states on 16-nov-2020 regarding an unsolicited valid serious case received from a patient via social media.This case involves an unknown age patient who had treatment with the medical device hylan g-f 20, sodium hyaluronate (synvisc one) and was non-ambulatory for multiple days.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate shots (dose, frequency, formulation, route, indication, lot: unknown).There will be no information available on the batch number for this case.Since an unknown date, after the hylan g-f 20, sodium hyaluronate shots (unknown latency), patient was non-ambulatory for multiple days (gait inability; event assessed as serious due to disability).Patient wanted to know suggestions for treatments for relief of the side effects.Action taken: not applicable.It was not reported if the patient received a corrective treatment.Outcome: unknown.A product technical complaint was initiated, and results were 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: 10866549
• MDR Text Key: 219310943
• Report Number: 2246315-2020-00159
• 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
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• 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): Disability