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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Arthralgia (2355)

Event Type  Injury  

Event Description

Did get a cortisone injection after synvisc one (prescriber would allow a cortisone injection, if the synvisc-one was not working on the pain)/still feeling pain (right knee) [aching (r) knee] ([device ineffective]). Case narrative: the case is linked to (b)(4) (multiple device; same patient). Initial information received on 08-apr-2021 regarding an unsolicited valid serious case from a consumer/non-hcp from united states. This case involves an unknown age male patient who did get a cortisone injection after synvisc one (prescriber would allow a cortisone injection, if the synvisc-one was not working on the pain)/still feeling pain (right knee), while using the 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 an unknown date in (b)(6) 2020, patient received treatment with hylan g-f 20, sodium hyaluronate solution for injection in right knee at dose of 6 ml once (route and batch number unknown) for pain. On an unknown date, after unknown latency, patient got a cortisone injection and it was reported that prescriber would allow a cortisone injection, if the hylan g-f 20, sodium hyaluronate was not working on the pain) and still feeling pain (arthralgia) (device ineffective) (seriousness criteria: intervention required). Action taken: not applicable. Corrective treatment: cortisone injection. The patient outcome is reported as unknown.

• 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: 11664219
• MDR Text Key: 261746828
• Report Number: 2246315-2021-00090
• 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,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 04/14/2021 Patient Sequence Number: 1