BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE

    MDR report key: 7037473 · Received November 15, 2017

    Report

    Report Number
    MW5073376
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    October 19, 2017
    Report Date
    November 13, 2017
    Manufacturer
    MEDLINE
    Product Code
    GDX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING LIPOMA RE-EXCISION, THE DR WAS MAKING A STABBING MOTION INCISION TO PLACE A PENROSE DRAIN WHEN THE SCALPEL BLADE BROKE OFF IN THE PT'S BACK. THE BLADE WAS LOCATED ON X-RAY; HOWEVER, THE DR WAS UNABLE TO RETRIEVE THE BLADE AFTER TWO ATTEMPTS. THE WOUND WAS CLOSED WITH THE SCALPEL BLADE REMAINING IN THE PT AND THE PT HAS BEEN REFERRED TO A LOCAL SURGEON TO HAVE THE BLADE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814612 MEDLINE DISPOSABLE SAFTY SCALPEL GDX MEDLINE U00081

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other