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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 case was cross referred with case: (b)(4) (cluster) this spontaneous case from united states was received on 30-jan-2018 from healthcare professional this case concerns (b)(6) female patient who initiated treatment with synvisc one and after an unknown latency had lot of pain in right knee. Also a device malfunction was note for the reported lot number. No previous medications and concomitant medications were reported. Patient had compartmental chondral disease, large ganglion adjacent to medial tibial plateau, tricompartmental osteoarthritis and was acl deficient. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml (frequency: not provided) (batch/ lot number: 7rsl021 and expiry date: may-2020) for osteoarthritis. On an unknown date after an unknown latency, patient had lot of pain in right knee. She was advised to ice and use 800 mg ibuprofen every 6 hrs. Corrective treatment: ice and ibuprofen for lot of pain in right knee 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: 30-jan-2018: this case concerns a female patient who received synvisc one. Later patient had and later had right knee pain. A temporal relationship can be established with the product administration. Also, the concerned lot number has been identified to have malfunction by the company. Thus, 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 Key7285158
MDR Text Key100917803
Report Number2246315-2018-00324
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 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date05/01/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/30/2018
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: 02/21/2018 Patient Sequence Number: 1
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