• 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); Pain (1994); Swelling (2091)
Event Date 01/01/2017
Event Type  malfunction  
Event Description
(b)(4). This unsolicited case from united states was received on 12-dec-217 from other non-health care professional this case concerns (b)(6) female patient who received treatment with synvisc one and after an unknown latency had pain in the left knee and swelling in the left knee. Also, device malfunction was identified for the reported lot number. No medical history, previous medications, concomitant medications and concurrent conditions were reported. On (b)(6) 2017, patients received treatment with intra articular synvisc one injection once (dose, indication and expiration date: not provided) with batch/ lot number: 7rsl021 in left knee. On an unknown date in 2017, latency unknown, patient experienced pain and swelling in the left knee. Patient was instructed by the personal assistant (pa) to ice, elevated and use nsaids. Patient was also told to call if the symptoms did not resolve within one week's time. Corrective treatment: not reported for device malfunction; ice, elevated and use nsaids for pain in the left knee and swelling in the left knee 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 was completed, corrective and preventive actions would be implemented. Seriousness criterion: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 20-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced pain and swelling in the left knee. A plausible relationship between the suspect and event cannot be denied. 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.
 
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 Key7171090
MDR Text Key97822124
Report Number2246315-2017-00433
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 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2018
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 Received12/12/2017
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: 01/08/2018 Patient Sequence Number: 1
-
-