BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPATCH 3151

    MDR report key: 1637204 · Received March 19, 2010

    Report

    Report Number
    2648988-2010-00019
    Event Type
    Other
    Date Received
    March 19, 2010
    Date of Event
    April 4, 2008
    Report Date
    March 19, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RECENT INTERNAL AUDIT OF INVESTIGATED COMPLAINTS THAT HAVE BEEN RECEIVED DURING THE PAST TWO YRS DETERMINED THAT THIS EVENT, THAT FULFILLS INTEGRA LIFESCIENCES CORP'S REPORTING REQUIREMENTS, WAS NOT REPORTED PREVIOUSLY TO THE FDA. NO LOT NUMBER WAS PROVIDED AND NO PRODUCT COMPLAINT SAMPLE WAS AVAILABLE FOR RETURN FOR EXAMINATION. AS A RESULT, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. INTEGRA'S INVESTIGATION WAS UNABLE TO CONFIRM THE COMPLAINT. NO CORRECTIVE ACTION IS CONSIDERED TO BE NECESSARY. THE COMPLAINT RATE FOR THIS PRODUCT FAMILY IS 0.0005%. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A BIOPATCH WAS USED AS A DRESSING ON THE INSERTION SITE OF A SUBCLAVIAN TRIPLE LUMEN CATHETER THAT WAS IN PLACE TO ADMINISTER NORMAL SALINE AND INTRAVENOUS MEDICATION. THE CATHETER WAS IN PLACE FOR FIVE DAYS. WHEN THE BIOPATCH DRESSING WAS CHANGED AFTER FIVE DAYS, THERE WAS NO ABNORMALITY NOTED. AFTER A FURTHER FIVE DAYS, PUS AND REDNESS WERE OBSERVED AT THE CATHETER INSERTION SITE. ON REMOVAL OF THE CATHETER, THE CATHETER TIP WAS SENT FOR BACTERIAL CULTURE. THE RESULTS OF THE CULTURE WERE NEGATIVE. A NEW SUBCLAVIAN LINE WAS INSERTED AT A SITE ON THE PT'S OPPOSITE SIDE. NO FURTHER TREATMENT WAS PROVIDED. BIOPATCH WAS USED AGAIN ON THIS PT WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPATCH 3151 ANTIMICROBIAL PRODUCTS FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other