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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ Back to Search Results
Lot Number ARSP003C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Bacterial Infection (1735); Ambulation Difficulties (2544)
Event Date 02/07/2022
Event Type  Injury  
Manufacturer Narrative
Sanofi company comment on 05-mar-2022: this case involves a (b)(6) male patient who experienced bilateral septic arthritis in the knees after infiltration with synvisc with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc]. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
 
Event Description
Bilateral septic arthritis in the knees after infiltration with synvisc [septic arthritis]. Case narrative: initial information received on 25-feb-2022 from italy regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a (b)(6) male patient who experienced bilateral septic arthritis in the knees after infiltration with synvisc with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate, injection (strength, dosage, frequency, route, batch number, indication, expiration date: unknown). On (b)(6) 2022 (latency: unknown), the patient developed bilateral septic arthritis in the knees after infiltration with synvisc (arthritis bacterial). This event was assessed as medically significant and was leading to disability. Action taken: unknown. It was not reported if the patient received a corrective treatment for the event (bilateral septic arthritis in the knees after infiltration with synvisc). At time of reporting, the outcome was not recovered /not resolved for the event bilateral septic arthritis in the knees after infiltration with synvisc.
 
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Brand NameSYNVISC
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 Key13685182
MDR Text Key291308636
Report Number2246315-2022-00021
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,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberARSP003C
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: 03/07/2022 Patient Sequence Number: 1
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