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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 Problem Pain (1994)
Event Type  malfunction  
Event Description
This spontaneous case from united states was received on (b)(6) 2018 from the patient. This case concerns a patient (demographics not provided) who initiated treatment with synvisc one and after unknown latency had device malfunction and increased pain. No medical history, previous medications, concurrent conditions or concomitant medications were reported. On an unknown date, patient received treatment with intra articular synvisc one injection (unknown dose) (batch/ lot number: 7rsl021 and expiry date: unknown). On unknown dates, after unknown latencies, the patient had device malfunction and increased pain. The patient had increased pain for 3 weeks. Later it was found that this lot number had been recalled. Event abated after use stopped or dose reduced. Action taken: unknown corrective treatment: not reported for both events outcome: unknown for both events seriousness criteria: important medical event for device malfunction 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. Pharmacovigilance comment: sanofi company comment dated 27-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced increased pain. A temporal relationship can be established with the product administration. Furthermore, the concerned lot number 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 Key7330893
MDR Text Key102353405
Report Number2246315-2018-00378
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 Patient
Remedial Action Recall
Type of Report Initial
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 03/12/2018 Patient Sequence Number: 1
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