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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); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)
Event Date 11/22/2017
Event Type  malfunction  
Event Description
This unsolicited case from united states was received on (b)(6) 2018 from patient. This case involves a patient (demographics: not provided) who received treatment with synvisc one and after few days the patient had trouble walking, pain, redness and swelling (after unknown latency). Also, device malfunction was identified for the reported lot number. No medical history, past drugs, concurrent condition was provided. Concomitant medications included simvastatin, amlodipine, alprazolam, metoprolol tartrate (metoprolol), fish oil, low dose acetylsalicylic acid (aspirin). On an unknown date in 2017, the patient initiated treatment with intra-articular, injection (dose: not provided; batch/lot number: 7rsl021) for pain relief for knee. It was reported that the patient had an injection of synvisc one which was from a contaminated lot lot #7rsl021. On (b)(6) 2017 (after unknown latency), the patient experienced pain, swelling, redness, trouble walking, was later called by physician to be informed of the contamination. The patient had to go to the hospital for blood tests, apparently the blood tests were satisfactory. The blood tests were done a month later but had lesser levels of pain and swelling for 2 months. It was reported that the problem did not stop after the patient reduced the dose or stopped taking or using the product. Corrective treatment: not reported for all events. Outcome: recovering for pain, swelling; unknown for rest of the events. Seriousness criterion: important medical event for device malfunction was identified for the reported lot number. A product technical complaint (ptc) was initiated and results were pending for the same. 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 was under investigation. Once this investigation would be completed, corrective and preventive actions would be implemented. Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018: this case concerns a patient who suffered experienced to being unable to walk after receiving synvisc one injection from the recalled lot. The temporal relationship can still be established between the events and the suspect product based on the available information. Additionally, as the concerned lot number has been identified to have malfunction by the company. Therefore, pharmacological plausibility 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 Key7510564
MDR Text Key108734713
Report Number2246315-2018-00474
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
Type of Report Initial
Report Date 04/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/30/2018
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: 05/14/2018 Patient Sequence Number: 1
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