BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPATCH 3150

    MDR report key: 1565422 · Received December 22, 2009

    Report

    Report Number
    2648988-2009-00067
    Event Type
    Other
    Date Received
    December 22, 2009
    Date of Event
    August 1, 2009
    Report Date
    December 22, 2009
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURN WAS EXPECTED. THERE WAS NO PRODUCT RETURNED FOR EVALUATION AND NO LOT NUMBER WAS PROVIDED; THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS PART OF THIS INVESTIGATION. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM SINCE YEAR 2008, THE COMPLAINT RATIO FOR THIS TYPE OF INCIDENT IS 0.00013%. REGARDING THE ALLEGED DISINTEGRATION OF THE FOAM IN THE FIRST 24 HOURS, AS STATED BY CUSTOMER IN COMPLAINT NOTIFICATION, NO OTHER SIMILAR COMPLAINT HAS BEEN REGISTERED SINCE YEAR 2008. THE PRIMARY FUNCTION OF THE FOAM PART OF THE BIOPATCH IS TO SWELL, AS THE PT'S EXUDATES ARE BEING ABSORBED; THEREFORE, DISINTEGRATION OF THE FOAM WOULD BE HIGHLY IMPROBABLE. GIVEN THE DESCRIPTION OF THE EVENT AND LACK OF RETURNED PRODUCT, THE REPORTED CONDITION CANNOT BE CONFIRMED AND NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. NO CORRECTIVE/PREVENTIVE ACTIONS WILL BE PURSUED, SINCE THE CONDITION IS NOT RELATED TO A MALFUNCTION OF THE BIOPATCH UNIT. INTEGRA WILL CONTINUE TO MONITOR THIS TYPE OF INCIDENT FOR TRENDING PURPOSES. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING USE OF THE PRODUCT WITH A PICC, (PERIPHERALLY INSERTED CENTRAL CATHETER), THE FOAM PART OF THE BIOPATCH DISINTEGRATED. THE EVENT OCCURRED SEVERAL MONTHS AGO. THE LENGTH OF TIME THAT THE PRODUCT WAS IN PLACE WAS NOT SPECIFIED, BUT WAS REPORTED IT WAS NOT ON THE PT FOR VERY LONG. THE PT ALSO HAD REDNESS EXTENDING BEYOND THE PRODUCT. ANOTHER BIOPATCH WAS USED. THE FOAM PART ALSO DISINTEGRATED AND THE PT HAD REDNESS AGAIN. THE BIOPATCH WAS REMOVED, THE SKIN CLEANSED WITH CHOLORPREP AND THE AREA COVERED WITH A GAUZE DRESSING AND THE AREA HEALED. NO PRODUCT IS AVAILABLE FOR RETURN FOR ANALYSIS. THE USER FACILITY REPORTED THAT THE LOT NUMBER WAS UNKNOWN BUT THIS WAS THE ONLY REACTION NOTED WHEN THIS LOT WAS USED.

    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 LET DRY/APPLY BIOPATCH| COVER WITH TEGADERM| CHLOROPREP TO CLEANSE