BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERINET SHOE COVER W/EXTRA TRACTION, XL

    MDR report key: 624493 · Received August 5, 2005

    Report

    Report Number
    1033422-2005-00049
    Event Type
    Injury
    Date Received
    August 5, 2005
    Date of Event
    June 5, 2005
    Report Date
    August 5, 2005
    Manufacturer
    KIMBERLY-CLARK CORP.
    Product Code
    BWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "THE SHOE COVER WAS DETERMINED A CAUSE IN A FALL THAT HAPPENED 2 MONTH AGO". (THE EVENT DATE PROVIDED IS AN ESTIMATED DATA BASED ON 60 DAYS PRIOR TO THE MDR REPORT DATE). A HOSP SAFETY COMMITTEE'S INVESTIGATION FOUND THAT THE NURSE SUSTAINED A FACIAL INJURY AFTER HITTING THEIR HEAD IN THE FALL AND REQUIRED STITCHES. THEY ARE IN THE FALL AND REQUIRED STITCHES. THEY ARE BACK AT WORK NOW. THE HOSP DID NOT HAVE THE LOT NUMBER NOT THE DATE OF THE FALL. KIMBERLY-CLARK CORPORATION HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS, BUT IS RELAYING INFORMATION RECEIVED FROM OUTSIDE SOURCES PURSUANT TO FEDERAL REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERINET SHOE COVER W/EXTRA TRACTION, XL SHOE COVER BWP KIMBERLY-CLARK CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention