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

Lot Number ARSP005C

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

Patient Problems Arthritis (1723); Neuropathy (1983); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Issues with her sciatic nerve being pinched [pinched nerve].Having less difficulty however does walk with a cane and is careful [walking difficulty].Get some tests done for arthritis/ has some in her knees as well as her back [arthritis].Case narrative: initial information received on 15-may-2023 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: unknown; country: canada.Study title: patient support program involving synvisc.This case involves an elderly female patient who was having less difficulty however does walk with a cane, issues with her sciatic nerve being pinched, and was careful and get some tests done for arthritis/ had some in her knees as well as her back with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.It was unknown if the patient had any concomitant disease or risk factor.On (b)(6)2021, the patient received 1st hylan g-f 20, sodium hyaluronate injection in her left knee at a dose of 2ml 3x intra-articular (lot - arsp005c, expiry date, indication and strength).On an unknown date after unknown latency, the patient had an issues with her sciatic nerve being pinched (nerve compression).She was having less difficulty however did walk with a cane and was careful (gait disturbance), which was helping her.As on her physician request the patient get some tests done for arthritis and would see a specialist regarding her results for arthritis.She had some in her knees as well as her back (arthritis).Action taken: no action taken for all events.Corrective treatment: walk with a cane for all the events.At time of reporting, the outcome was unknown for the event having less difficulty however does walk with a cane and is careful and not recovered for rest of the events.Reporter causality: not reported for all events.Company causality: not reportable for all events.Seriousness criteria: disability for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

• Brand Name: SYNVISC
• Type of Device: MOZ
• 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: 17017199
• MDR Text Key: 316196482
• Report Number: 2246315-2023-00052
• 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: Foreign,Study,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: ARSP005C
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2023
• 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
• Patient Sex: Female