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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number 7RSL021
Device Problem Device Contamination With Biological Material (2908)
Patient Problems Swelling (2091); Discomfort (2330); Reaction, Injection Site (2442)
Event Date 01/26/2018
Event Type  malfunction  
Event Description
Based on the information received on 13-mar-2018 the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction. This case was cross referred with: (b)(4) (cluster). This spontaneous case from united states was received on 26-jan-2018 from other non health care professional this case concerns a female patient (age unknown) who initiated treatment with synvisc one and after an unknown latency had some swelling and discomfort. Also, device malfunction was identified for the reported lot number. No medical history, previous medications, concomitant medications and concurrent conditions were reported. On an unknown date, patient received treatment with intra articular synvisc one injection (batch/lot number: 7rsl021; expiry date: unknown) (indication, frequency, dose: unknown). On an unknown date after an unknown latency had some swelling and discomfort. Action taken: unknown. Corrective treatment: not reported for all events. Outcome: unknown for all events. A product technical complaint was initiated with (b)(4). An investigation was initiated as a result of an unexpected increase in the number of labelled 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. The cause of these events is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Seriousness criteria: important medical event for device malfunction. Additional information was received on 13-mar-2018. Additional event of device malfunction was added. Global ptc number and ptc results were added. Text amended accordingly. Pharmacovigilance comment: sanofi company comment dated 21-mar-2018: this case concerns a patient who had received synvisc-one injection from re-called lot and later developed swelling and discomfort. The temporal relationship is significant and hence, causal role of suspect product cannot be ruled out in occurrence of the event. Furthermore, the concerned lot has been identified to have malfunction by the company. Therefore, the causal relationship of the events to the products cannot be excluded.
 
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Brand NameSYNVISC ONE
Type of DeviceINTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive
55b-220a
bridgewater, NJ 08807
9089817289
MDR Report Key7380921
MDR Text Key104154971
Report Number2246315-2018-00416
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Recall
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/13/2018
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/29/2018 Patient Sequence Number: 1
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