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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
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.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
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 Key12966739
MDR Text Key285319820
Report Number2246315-2021-00180
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation
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 Received12/09/2021
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 Treatment Data
Date Received: 12/09/2021 Patient Sequence Number: 1
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