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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 Pain (1994); Swelling (2091); Reaction (2414); Reaction, Injection Site (2442)
Event Date 11/22/2017
Event Type  malfunction  
Event Description
This unsolicited case from united states was received on 13-feb-2018 from patient. This case concerns a female patient (age unspecified) who received treatment with synvisc one and on the same day had skin issues, massive swelling lasting for day, lots of pain, very sick, flu like and stomach issues. Also, device malfunction was identified for the reported lot number. No past drugs, medical history, concomitant medications and concurrent conditions were reported. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once (lot number: 7rsl021; dose, indication and expiration date: not reported). On the same day, after the injection, patient had massive swelling lasting for day, very sick, flu like, stomach issues, skin issues and lots of pain. Corrective treatment: not reported for all events. Outcome: recovered for massive swelling lasting for day; unknown for rest 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 20-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced massive swelling, very sick, flu like, stomach issues, skin issues and lots of pain. A temporal relationship can be established with the product administration. In addition, the concerned lot number has been identified to have malfunction by the company, hence, 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 Key7288233
MDR Text Key101135488
Report Number2246315-2018-00333
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 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
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 Received02/13/2018
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: 02/22/2018 Patient Sequence Number: 1
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