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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, Injection Site (2442)
Event Date 11/28/2017
Event Type  malfunction  
Event Description
This case was cross reference with case id: (b)(4) (cluster). This unsolicited case from united states was received on 28-feb-2018 from other non-health care professional. This case concerns a (b)(6) year old female patient who received treatment with synvisc one and after one day had increase pain in both knees/both knees have been aching and throbbing and swelling in both knees. Also, device malfunction was identified for the reported lot number. No medical history, past drug, concomitant medication or concurrent condition was provided. On (b)(6) 2017, the patient initiated treatment with single intra-articular synvisc one injection, one dosage form once (batch/lot number: 7rsl021; indication and expiry date: not reported) bilaterally. On (b)(6) 2017, after one day of receiving injection, patient had increase pain and swelling in both knees. Patient said that both knees have been aching and throbbing. Corrective treatment: not reported for all events. Outcome: unknown 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 is completed, corrective and preventive actions would be implemented. Seriousness criterion: important medical event for device malfunction. Pharmacovigilance comment: sanofi company comment dated 8-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later had knee pain and 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 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 Key7331033
MDR Text Key102339679
Report Number2246315-2018-00372
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
Remedial Action Recall
Type of Report Initial
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received02/28/2018
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: 03/12/2018 Patient Sequence Number: 1
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