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

Lot Number BRSL015

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

Patient Problems Neuropathy (1983); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Legs were beginning to not hold me up [weight bearing difficulty]. Moderate to severe neuropathy [neuropathy]. Withdrew fluid [knee effusion]. Felt strange [feeling strange]. Severe pain all over my body [general body pain]. Case narrative: initial information received from (b)(6) on (b)(6) 2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This case involves (b)(6) female patient who experienced moderate to severe neuropathy, had fluid withdrawn, legs were beginning to not hold her up, felt strange and had severe pain all over my body while being treated with the use of medical device hylan g-f 20,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 (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate solution for injection at a dose of 6 ml once (lot - unknown) for osteoarthritis. By the time patient left the doctor's office, her legs were beginning to not hold her up (weight bearing difficulty; onset: (b)(6) 2021; latency: same day; seriousness: intervention required) felt strange (feeling abnormal; onset: (b)(6) 2021; latency: same day) and had severe pain all over body (pain; onset: (b)(6) 2021; latency: same day). The patient went to a doc-in-the-box (urgent care) 3 times and the emergency room (er) 2 times. The doctor who did the injections withdrew fluid (joint effusion; latency: unknown; seriousness: medically significant and intervention required) and injected cortisone on an unknown date in 2021. Now the patient was under treatment by a rheumatologist and was on more medications. A neurologist did 'muscle stim' testing and determined that had moderate to severe neuropathy as a result of the injections (neuropathy peripheral; onset: 2021; latency: unknown; seriousness: medically significant). Action taken: not applicable. The patient was treated with cortisone acetate for weight bearing difficulty; fluid was withdrawn for joint effusion; no other treatment reported. At time of reporting, the outcome was not recovered / not resolved for all events.

• 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: 13018085
• Report Number: 2246315-2021-00181
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: BRSL015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: Female
• Patient Weight: KG
• Patient Outcome(s): Other; Required Intervention