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 Problems Arthralgia (2355); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2021

Event Type  Injury  

Event Description

After the injection her knee blew up immediately, that she iced the knee for 2 days, had swelling, a big lump on the left side of the knee [swelling of l knee] pain so she iced it for 2 days/painful for a month [aching (l) knee] who drained the fluid [knee effusion] she couldn't walk for a month [unable to walk].Case narrative: initial information received on 15-oct-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states.This case involves (b)(6) female patient who reported that after the injection her knee blew up immediately, that she iced the knee for 2 days, had swelling, a big lump on the left side of the knee, pain so she iced it for 2 days/painful for a month, she couldn't walk for a month and who drained the fluid 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 (route, strength, batch number and expiry date: unknown) for osteoarthritis.On (b)(6) 2021 the patient knee blew up immediately, that she iced the knee for 2 days, had swelling, a big lump on the left side of the knee (joint swelling; seriousness: intervention required; latency: same day) and had pain so she iced it for 2 days but the swelling didn't go down (arthralgia; seriousness: intervention required; onset: (b)(6) 2021 and latency: few days).It was reported that patient could not walk (gait inability; onset: (b)(6) 2021 and latency: few days).On an unknown date in (b)(6) 2021, the patient went back to her doctor who drained the fluid (joint effusion; seriousness: intervention required and medically significant; latency: unknown), gave her cortisone and now she was much better.Patient reported that she was never getting the injection again.Action taken: not applicable for all events.Corrective treatment: cortisone and ice for joint swelling; arthralgia and joint effusion; not reported for gait inability.Outcome: recovering for all events.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 12704715
• MDR Text Key: 284314222
• Report Number: 2246315-2021-00168
• 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: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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
• 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 Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention