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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 , 7RSL019
Device Problem Device Contamination With Biological Material (2908)
Patient Problems Pain (1994); Cramp(s) (2193); Ambulation Difficulties (2544)
Event Date 11/20/2017
Event Type  malfunction  
Event Description
(b)(4). This unsolicited case from united states was received on 08-dec-2017 from a nurse. This case concerns (b)(6) female patient who received treatment with synvisc one and later after 4 days of receiving injection patient was unable to walk, had pain in legs and cramping in legs. Also device malfunction was identified for the reported lot number. No past drug, medical history, concomitant medication or concurrent condition was provided. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 1 df once (batch/lot number: 7rsl021, expiry date: unknown) for right knee arthritis in right knee. On (b)(6) 2017, after 4 days of receiving injection, patient called stating that she was unable to walk due to pain and cramping in her legs. Patient was sent for a doppler/ dvt (deep vein thrombosis) which was negative. Patient has not called back since corrective treatment: not reported for device malfunction; rest, ice and elevate and take anti-inflammatory medications for rest 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 was under investigation. Once this investigation would be completed, corrective and preventive actions would be implemented. Seriousness criteria: important medical event for device malfunction. Pharmacovigilance comment: sanofi company comment for follow up dated 8-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and was unable to walk due to pain and cramping in legs. 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 Key7177966
MDR Text Key97860975
Report Number2246315-2018-00097
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,Followup,Followup
Report Date 12/08/2017
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 Lot Number7RSL021 , 7RSL019
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 Received04/16/2018
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: 01/10/2018 Patient Sequence Number: 1
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