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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 Erythema (1840); Swelling (2091)
Event Date 12/01/2017
Event Type  malfunction  
Event Description
This unsolicited case from united states was received on 12-dec-2017 from nurse. This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and after unknown latency her left knee was locked in extension, had thigh swelling, red left knee/ red thigh, swollen left knee and was unable to bend the left knee. Also, device malfunction was identified for the reported lot number. No medical history, past drug, concomitant medication and concurrent condition was provided. On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: 31-may-2020) in each knee for osteoarthritis knee pain. On an unknown date in (b)(6) 2017, after unknown latency, the patient experienced an adverse reaction only in her left knee, consisting of a red and swollen left knee and thigh, and the left knee was locked in extension, and the patient was unable to bend the left knee. Also, device malfunction was identified for the reported lot number on an unknown date in (b)(6) 2017. Corrective treatment: not reported for all events. Outcome: not recovered for all events. 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 pharmacovigilance comment: sanofi company comment dated 12-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced joint lock, swelling of leg, joint range of motion, localized erythema and left knee swelling. 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 product 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 Key7177796
MDR Text Key97802984
Report Number2246315-2017-00374
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 health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/12/2017
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: 01/10/2018 Patient Sequence Number: 1
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