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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 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problem Injury (2348)
Event Type  Injury  
Event Description
Injured as a result of the use of synvisc-one [injury associated with device] ([device malfunction]). Case narrative: initial information received on 04-mar-2020 regarding an unsolicited valid serious case received from a lawyer and healthcare professional. This case involves a patient of unknown demographics who was injured as a result of the use of hylan g-f 20, sodium hyaluronate (synvisc one). A device malfunction was noted in the reported batch number. The case is linked to (b)(4) (duplicate). 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 (formulation, dose, indication, frequency: unknown) (lot - 7rsl021) for product used for unknown indication. On an unknown date, after unknown latency, patient had injury due to hylan g-f 20, sodium hyaluronate (medically significant). Action taken: not applicable. It was not reported if the patient received a corrective treatment. Outcome: unknown. A product technical compliant was initiated on 16-dec-2019 for synvisc one with batch number: 7rsl021 and global ptc number: (b)(4). Investigation was initiated for increase number of reported aes. An investigation was initiated as a result of an unexpected increase in the number of labeled adverse events received from the us market for synvisc one lot 7rsl021. The product met all release testing at time of manufacture in june 2017. Retain samples were retested due to the unexpected increase in adverse events. Higher than expected endotoxin results were obtained. In addition, the presence of microbial contamination was also confirmed. An investigation ((b)(4)) was performed and capas were identified with timelines for implementation of these capas. Investigation complete date: 04-mar-2020.
 
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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 Key9842412
MDR Text Key196575499
Report Number2246315-2020-00048
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 health professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
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: 03/17/2020 Patient Sequence Number: 1
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