BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARPLASE DUAL EFFECT

    MDR report key: 26363 · Received August 9, 1995

    Report

    Report Number
    26363
    Event Type
    Injury
    Date Received
    August 9, 1995
    Date of Event
    April 13, 1995
    Report Date
    May 2, 1995
    Manufacturer
    SHARPLIN LASERS, INC.
    Product Code
    HHR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LASER TIP BROKE OFF DURING SURGERY AND EMBEDDED IN UTERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPLASE DUAL EFFECT Implant 600 BARE FIBRE HHR SHARPLIN LASERS, INC. 25389 305 392

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention