• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Bacterial Infection (1735); Sepsis (2067); Toxicity (2333)
Event Type  malfunction  
Event Description
Based on the information received on 08-dec-2017, the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction. This case is cross referenced with case: (b)(4) (cluster). This unsolicited case from united states was received on 08-dec-2017 from a non-healthcare professional. This case concerns a patient of unknown age and gender who received treatment with synvisc one and later after unknown latency patient had pseudosepsis. Also, device malfunction was identified for the reported lot number. No past drug, medical history, concomitant medication or concurrent condition was provided. On an unknown date, the patient initiated treatment with intra-articular synvisc one injection once (dose, indication and expiry date: unknown) (batch/lot number: 7rsl021). On an unknown date, after unknown latency the patient had pseudosepsis. Action taken: unknown. Corrective treatment: not reported for both events outcome: unknown for both 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 was completed, corrective and preventive actions would be implemented. Seriousness criterion: important medical event for device malfunction additional information was received on 08-dec-2017 and 29-dec-2017 (both information processed together with clock stat date of 08-dec-2017). This case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction. Event of device malfunction was added. Global ptc number and ptc results were added. Clinical course updated. Text was amended accordingly pharmacovigilance comment: sanofi company comment for follow up dated 08-dec-2017: this case concerns a patient who received synvisc one injection from the recalled lot and had pseudosepsis. As the concerned lot number has been identified to have malfunction by the company, the causal relationship of suspect product cannot be ruled out with the occurrence of adverse events.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7186973
MDR Text Key98006708
Report Number2246315-2018-00118
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 12/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2018
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 Received12/08/2017
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: 01/12/2018 Patient Sequence Number: 1
-
-