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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
Lot Number ARSL019B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Synovitis (2094)
Event Type  Injury  
Event Description
Discovered the bacteria [bacterial infection nos] synovitis [synovitis] case narrative: this case was cross linked to (b)(4) (cluster). Initial information received on 23-sep-2021 regarding an unsolicited valid serious case received from the patient from (b)(6). This case involves an unknown age male patient who experienced synovitis and microbiologist discovered the bacteria while being treated with 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, the patient started taking hylan g-f 20, sodium hyaluronate injection ( indication, dose, route, strength: unknown) (lot - arsl019b, expiry date: 30-apr-2023). On an unknown date after unknown latency patient developed synovitis (seriousness: medically significant and hospitalization). Patient went to see a doctor at and the microbiologist discovered that the bacteria (bacterial infection) was from the product and not from the patient. The patient was currently hospitalized. Action taken with hylan g-f 20, sodium hyaluronate was not applicable. It was not reported if the patient received a corrective treatment for the events (synovitis, discovered the bacteria). At time of reporting, the outcome was unknown for the event synovitis and was unknown for the event discovered the bacteria.
 
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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 Key12547611
MDR Text Key281022561
Report Number2246315-2021-00160
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberARSL019B
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: 09/29/2021 Patient Sequence Number: 1
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