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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 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.
 
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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 Key11664219
MDR Text Key261746828
Report Number2246315-2021-00090
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 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 Received04/14/2021
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
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