BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPATCH

    MDR report key: 1637202 · Received March 19, 2010

    Report

    Report Number
    2648988-2010-00017
    Event Type
    Other
    Date Received
    March 19, 2010
    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 HAD 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 PRODUCT WAS RECEIVED FOR EVALUATION. NO LOT NUMBER WAS PROVIDED, THEREFORE, DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. NO ROOT CAUSE FOR THIS EVENT COULD BE DETERMINED. NO CORRECTIVE ACTION WAS TAKEN. BIOPATCH PRODUCTS ARE A TOPICAL ANTIMICROBIAL SYSTEM. THE PT HAD LEUKEMIA AND WAS UNDERGOING CHEMOTHERAPY. IT IS KNOWN THAT THIS SEVERELY COMPROMISES THE PT'S IMMUNE SYS. THE INFECTION WAS NOTED ONE WEEK AFTER THE USE OF THE KIT WITH THE BIOPATCH. 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 THE USER FACILITY USED A CARDINAL CENTRAL LINE DRESSING PACK KIT THAT CONTAINED A BIOPATCH DRESSING. THE PT INVOLVED HAD A CENTRAL LINE PLACED AND THE BIOPATCH FROM THE KIT WAS USED ON THE INSERTION SITE. THE PT'S CENTRAL LINE BECAME INFECTED AND EXUDATE WAS OBSERVED AT THE INSERTION SITE. THE CATHETER HAD BEEN IN FOR ABOUT ONE WEEK. THE EXUDATE FROM THE SITE OF THE CATHETER INSERTION WAS CULTURED AND GREW STAPHYLOCOCCUS. THE PT WAS TREATED WITH ANTIBIOTICS AND THE CATHETER WAS REMOVED. A NEW CATHETER WAS PLACED AT ANOTHER SITE. THE PT WAS FEBRILE FOR TWO WEEKS. THE PT HAD A MEDICAL HISTORY OF ACUTE MYLOID LEUKEMIA, AND HAD BEEN NEUTROPENIC FOR 30 DAYS AND WAS ON CHEMOTHERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other