BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTICAL ISOLATION DRAPE W/ MICROBAN

    MDR report key: 6541423 · Received May 3, 2017

    Report

    Report Number
    8043817-2017-00010
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Date of Event
    March 23, 2017
    Report Date
    April 6, 2017
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    KKX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES OR PICTURES WERE RECEIVED FOR THIS INVESTIGATION. THE DHR WAS REVIEWED FOR LOT D161952 AND IT WAS CONFIRMED THAT THIS LOT HAD (B)(4) UNITS THAT WERE MANUFACTURED ON 07/14/2016 AND THAT WAS MANUFACTURED ON THE FIRST SHIFT, NO DEFECTS WERE REPORTED DURING THE QUALITY INSPECTIONS. AWARENESS WAS GIVEN IN THE MANUFACTURING LINE IN ORDER TO MAKE THE OPERATORS AWARE OF THE NON CONFORMANCE REPORTED BY THE CUSTOMER. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME SINCE NO SAMPLES OR PICTURES WERE RECEIVED FOR THIS INVESTIGATION TO CONFIRM THE NON CONFORMANCE AND DURING THE PROCESS EVALUATION NO CONDITION THAT REQUIRES MITIGATION WAS OBSERVED. THE ROOT CAUSE OF THIS EVENT IS UNDETERMINED AND THE INVESTIGATION IS INCONCLUSIVE DUE TO INSUFFICIENT INFORMATION FROM THE FIELD.

    Description of Event or Problem · 1

    STICKY PORTION OF DRAPE IS NOT STICKY ENOUGH. PEELS AWAY FROM PATIENT. SURGEON FREQUENTLY NEEDS TO OPEN A LOBAN DRAPE AS WELL TO HELP IT ADHERE TO PATIENT. IN TODAY'S CASE IT WAS PEELING OFF SO BADLY SURGERY WAS STOPPED, INCISION WAS CLOSED AND DRAPES WERE REMOVED AND PATIENT WAS RE-DRAPED. PROBLEM CONTINUED WITH NEXT REPLACEMENT DRAPE- SAME DRAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320851 VERTICAL ISOLATION DRAPE W/ MICROBAN PATIENT DRAPES WITH MICROBAN KKX MICROTEK DOMINICANA, S.A. 29-91209 D161952

    Patients

    Seq Age Sex Outcome Treatment
    1