BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHOE COVER

    MDR report key: 2929384 · Received January 19, 2013

    Report

    Report Number
    1417592-2013-00006
    Event Type
    Other
    Date Received
    January 19, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 11, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    BWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A PIECE OF ELASTIC WAS FOUND IN THE DIAPER OF A CHILD IN THE DAY CARE SETTING AND THOUGHT TO HAVE COME FROM THE SHOE COVERS USED BY PARENTS AND STAFF. NO SAMPLE WAS RETURNED FOR EVAL. NO ONE WITNESSED THE CHILD WITH A PIECE OF ELASTIC IN HIS/HER MOUTH AND NO PREVIOUS COUGHING OR CHOKING WAS OBSERVED. NO PHOTOS WERE PROVIDED. WE HAVE NOT CONFIRMED THE SHOE COVER TO BE THE SOURCE OF THE ELASTIC PIECE FOUND IN THE DIAPER. WE HAVE NO TREND FOR THIS ISSUE. THERE WAS NO INJURY TO THE CHILD.

    Description of Event or Problem · 1

    CONCERN THAT A CHILD SWALLOWED A PIECE OF ELASTIC FROM A SHOE COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28593 SHOE COVER BWP MEDLINE INDUSTRIES, INC. 12GXFA0501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other