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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); Patient Problem/Medical Problem (2688)
Event Date 11/01/2017
Event Type  malfunction  
Event Description
Based upon additional information received on 22-nov- 2017, the case initially assessed as non-serious was upgraded to serious as the serious event of device malfunction with the seriousness criterion of important medical event was added. This case was cross referenced with (b)(4) (cluster). This unsolicited case from united states was received on 21-nov-2017 from the other non-health care professional. This case concerns a (b)(6) year old male patient who received treatment with synvisc one injection and after unknown latency the patient experienced right knee pain and right knee swelling; also, device malfunction was identified for the reported lot number. No relevant medical history, past medications and concomitant medications were reported. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, once (dose, indication and expiration date: not reported; lot number: 7rsl021). On an unknown date in (b)(6) 2017, unknown latency of receiving the injection the patient experienced right knee pain and knee swelling. Corrective treatment: not reported for all the events outcome: unknown for all the events. A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4). 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 criterion: important medical event (ime) for device malfunction additional information was received on 22-nov-2017. The serious event of device malfunction with the seriousness criterion of ime was added and the case was upgraded to serious. The ptc results were added. Text amended accordingly. Pharmacovigilance comment: sanofi company comment dated 22-nov-2017: this case concerns a patient who received treatment with synvisc one and later experienced right knee pain and right knee swelling. 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 Key7144586
MDR Text Key96392185
Report Number2246315-2017-00364
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 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
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 Received11/22/2017
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: 12/22/2017 Patient Sequence Number: 1
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