BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM CES ABD FC DRAPE FENSTD 150

    MDR report key: 6106853 · Received November 16, 2016

    Report

    Report Number
    3011270181-2016-00019
    Event Type
    Injury
    Date Received
    November 16, 2016
    Report Date
    October 31, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    KKX
    PMA / PMN Number
    PK86280
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). NO SAMPLE AVAILABLE.

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3011270181-2016-00018 FOR THE FIRST PATIENT. IT WAS REPORTED THAT A DRAPE LEAKED UNDER THE FENESTRATIONS DUE TO THE DRAPE NOT ADHERING TO THE SHAPE OF THE ABDOMEN. BLOOD AND FLUID LEAKED ON THE FLOOR AND RESULTED IN TWO STAFF MEMBERS FALLING. AS A RESULT OF THE FALL THE PATIENT HAD BRUISING ON THE HIP. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759070 CUSTOM CES ABD FC DRAPE FENSTD 150 SURGICAL DRAPES AND PACKS KKX HALYARD HEALTH 79528 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other