BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 3329731 · Received August 27, 2013

    Report

    Report Number
    3005011024-2013-00026
    Event Type
    Other
    Date Received
    August 27, 2013
    Date of Event
    August 8, 2013
    Report Date
    August 8, 2013
    Manufacturer
    DEROYAL LAFOLLETTE
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS NOT BEEN RETURNED FROM THE END USER AT THIS TIME FOR EVAL. THE COMPONENT REPORTED IS MANUFACTURED BY WELMED, INC. THE MANUFACTURER HAS BEEN NOTIFIED OF THE ISSUE AND INVESTIGATION INTO THE ROOT CAUSE IS IN PROCESS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT WELMED GOWNS IN THIS PACK AS WELL AS OTHER PACKS WITH WELMED GOWNS ARE RECEIVING COMPLAINTS FROM THE STAFF. THE SLEEVES OF THE WELMED GOWNS APPEAR TO BE SONIC WELDED OR HEAT BONDED DOWN THE LENGTH OF THE ARM. AT THE CUFF END OF THE SLEEVE THE FABRIC IS CUT AND SEWN TO THE WHITE COTTON CUFF. AT THE POINT WHERE IT IS CUT AT THE SONIC WELD, THE FABRIC APPEARS TO BE MELTED. THE WELD ON THE FABRIC IS CAUSING A PRICKLY SPOT AND IRRITATING THE WRISTS OF THE STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418026 DEROYAL KDD-KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL LAFOLLETTE 31262214

    Patients

    Seq Age Sex Outcome Treatment
    1 Other