BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPATCH 3150

    MDR report key: 1637203 · Received March 19, 2010

    Report

    Report Number
    2648988-2010-00020
    Event Type
    Other
    Date Received
    March 19, 2010
    Date of Event
    October 2, 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, THEREFORE, DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. NO COMPLAINT SAMPLE WAS RETURNED. THE DEVICE INSTRUCTIONS FOR USE WARNING SECTION STATES: ADVERSE REACTIONS TO CHLORHEXIDINE GLUCONATE SUCH AS DERMATITIS, HYPERSENSITIVITY, AND GENERALIZED ALLERGIC REACTIONS ARE VERY RARE, BUT IF SUCH REACTIONS OCCUR, DISCONTINUE THE USE OF THE DRESSING IMMEDIATELY. THE BIOPATCH OVERALL COMPLAINT RATE 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 DISTRIBUTOR'S SALES REP STATED THAT THE USER FACILITY REPORTED THAT A PT HAD REDNESS AND IRRITATION WITH DRAINAGE DEVELOP AT THE SITE WHERE THE BIOPATCH WAS USED. THE CATHETER INSERTION SITE WAS NOT AT A FEMORAL LOCATION. SKIN PREPARATION WAS ALLOWED TO DRY BEFORE THE PRODUCT WAS APPLIED. INTEGRA REQUESTED ADDITIONAL INFO. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPATCH 3150 ANTIMICROBIAL PRODUCTS FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 SKIN PREPARATION TO CLEANSE