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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 Problems Contamination (1120); Nonstandard Device (1420); Device Contamination With Biological Material (2908)
Patient Problems Bacterial Infection (1735); No Code Available (3191)
Event Type  malfunction  
Event Description
(b)(4).This unsolicited summary case from united states was received on 28-feb-2018 from a doctor.This case involves 7 patients (demographics not provided) who received treatment with synvisc one and after unknown latency experienced bacteria from the recalled synvisc one shots.No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported.On unknown dates, the patients received treatment with intra-articular synvisc one injection (dose, frequency, indication: not provided).On unknown dates, after unknown latencies, the patients had bacteria from the recalled synvisc one shots.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event.Pharmacovigilance comment: sanofi company comment dated 8-mar-2018: this case concerns a patient who received treatment with synvisc one and later experienced joint infection.Although a significant temporal relationship cannot be established, causal role of suspect product in occurrence of the event cannot be denied.However, information regarding medical history, concomitant medications, past drugs, event details will aid in medical assessment of the case.
 
Event Description
This case is cross referenced with case id (b)(4).(cluster).This unsolicited summary case from united states was received on 28-feb-2018 from a doctor.This case involves 7 patients (demographics not provided) who received treatment with synvisc one and after unknown latency experienced bacteria from the recalled synvisc one shots.Also device malfunction was noted in reported lot number.No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported.On unknown dates, the patients received treatment with intra-articular synvisc one injection (lot number: 7rsl021, dose, frequency, indication, expiration date: not provided).On unknown dates, after unknown latencies, the patients had bacteria from the recalled synvisc one shots.Action taken: unknown corrective treatment: not reported for bacteria from the recalled synvisc one shots outcome: unknown for both events a product technical complaint was initiated with global ptc number (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labeled 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 was completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for both events additional information on 26-mar-2018 from health care professional.Event of device malfunction was added.Global ptc number received and results processed.Pharmacovigilance comment: sanofi company commenty for follow up dated (b)(6) 2018:the follow up information does not change the previous case assessment.This case concerns a patient who received treatment with synvisc one and later experienced joint infection.Although a significant temporal relationship cannot be established, causal role of suspect product in occurrence of the event cannot be denied.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, pharmacological plausibility of the events to the product cannot be excluded.
 
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Brand Name
SYNVISC ONE
Type of Device
INTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
MDR Report Key7334417
MDR Text Key102314452
Report Number2246315-2018-00395
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/28/2018
Initial Date FDA Received03/13/2018
Supplement Dates Manufacturer Received03/26/2018
Supplement Dates FDA Received04/11/2018
Patient Sequence Number1
Patient Outcome(s) Other;
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