BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6064333 · Received October 28, 2016

    Report

    Report Number
    3011270181-2016-00016
    Event Type
    Injury
    Date Received
    October 28, 2016
    Report Date
    October 10, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    FXP
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS THE SPECIFIC DEVICE IS UNKNOWN AND NO LOT NUMBER WAS PROVIDED. 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). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FALL IN THE C-SECTION ROOM, DUE TO AN ALLEGED LACK OF TRACTION ON THE UNKNOWN SHOE COVER THE USER WAS WEARING. THE USER WAS TRYING TO MOVE A PATIENT TO THE OPERATING ROOM, AND BROKE HER ELBOW IN THE FALL. PER ADDITIONAL INFORMATION RECEIVED ON 12 OCT 2016, THE FALL OCCURRED AROUND THE END OF (B)(6) OR BEGINNING OF (B)(6). IT IS UNKNOWN HOW LONG THE USER WAS WEARING THE BOOTIES. THE FLOOR TYPE IN THE ROOM WAS LAMINATE, AND PER THE REPORTER, "AMNIOTIC FLUID WAS EVERYWHERE." THE USER WAS OUT OF WORK FOR 8-10 WEEKS AS A RESULT OF THE INJURY. TREATMENT INCLUDED THE ELBOW BEING IMMOBILIZED, AND PHYSICAL THERAPY, BUT NO SURGERY WAS REQUIRED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714470 UNKNOWN UNKNOWN SHOE COVER FXP HALYARD HEALTH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other