BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL GOWN REINFORCED XL FULLY AAMI I.V.

    MDR report key: 3217370 · Received May 24, 2013

    Report

    Report Number
    2648727-2013-00001
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 24, 2013
    Manufacturer
    EXACT MEDICAL MANUFACTURING (EMM)
    Product Code
    KKX
    PMA / PMN Number
    K120045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DHR REVIEW, QUALITY TESTS VERIFIED AND SPECIFICATIONS REPORTED AS VERIFIED BY MFR AND FAILURE OF DEVICE COULD NOT BE TRACED AS A DEFECT FROM MANUFACTURING PROCESS. END USER REQUESTED TO SUPPLY ANOTHER CATALOG UNTIL THE INVESTIGATION IS CLOSED. THE INVESTIGATION FROM THE DEVICE MFR DID NOT REVEALED DEFECT.

    Description of Event or Problem · 1

    DURING A PROCEDURE OF THE BLADDER BY LAPAROSCOPY, THE SURGEON HAD TO OPEN THE PATIENT (LAPAROTOMY) AND ENTERED HIS HANDS INTO THE CAVITY AND PERMEABILITY OF BLOOD AND WATER OCCURRED THROUGH SURGICAL GOWN CATALOG 1002493. THE LOT COULD NOT BE IDENTIFIED BY THE SURGEON. THE GOWN WAS INTO CUSTOMED SURGICAL PACK CATALOG NO. 900-028. THERE WERE TWO LOTS OF 1002493 TRACED AS USED. BOTH LOTS WERE REPORTED TO MFR EMM. EVENT OCCURRED IS ONLY ONE LOT. NO OTHER EVENT WAS REPORTED. THIS EVENT WAS REPORTED TO THE DEVICE MFR, EMM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230904 SURGICAL GOWN REINFORCED XL FULLY AAMI I.V. SURGICAL GOWN KKX EXACT MEDICAL MANUFACTURING (EMM) NO 1362APB2 AND 1742APB5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NO