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

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/13/2021

Event Type  Injury  

Event Description

Effect was not working any more no reported adverse event [therapeutic response shortened].Case narrative: initial information received on 02-dec-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional from (b)(6).This case involves a (b)(6) female patient who reported effect was not working any more.No reported adverse event 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 injection once for osteoarthritis (dose, route, strength, batch number and expiry date: unknown).On (b)(6) 2021, the patient reported that injection's effect was not working any more with no reported adverse event (therapeutic response shortened) 3 months after starting use of hylan g-f 20 and sodium hyaluronate.The patient was hospitalized for this event from 2021.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the event (lack of efficacy with no reported adverse event).At time of reporting, the outcome was unknown for the event lack of efficacy with no reported adverse event.

Event Description

Effect was not working any more no reported adverse event [therapeutic response shortened] case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional from canada.This case involves 75 years old female patient who reported effect was not working any more no reported adverse event 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 injection once for osteoarthritis (dose, route, strength, batch number and expiry date: unknown).On (b)(6) 2021 the patient reported that injection's effect was not working any more with no reported adverse event (therapeutic response shortened) 3 months after starting use of hylan g-f 20 and sodium hyaluronate.Action taken: not applicable it was not reported if the patient received a corrective treatment for the event (lack of efficacy with no reported adverse event).At time of reporting, the outcome was unknown for the event lack of efficacy with no reported adverse event.Based on information previously received on (b)(6) 2021, the following information [seriousness criteria was updated to non serious and other reportable incidents from eu/ca device was removed] has/have been amended.Local comments: *downgrade*.

• 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: 12966739
• MDR Text Key: 285319820
• Report Number: 2246315-2021-00180
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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): Required Intervention; Hospitalization
• Patient Sex: Female