BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKLAR INSTRUMENT

    MDR report key: 7933970 · Received October 3, 2018

    Report

    Report Number
    MW5080321
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    August 30, 2018
    Report Date
    September 12, 2018
    Manufacturer
    SKLAR CORP.
    Product Code
    HTD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ONE SIDE/BLADE OF THE FORCEPS BROKE OFF DURING A CIRCUMCISION PROCEDURE; 1 QTY HALSTEAD MOSQUITO FORCEPS, STERILE, 5¿ IN THE SKLAR STERILE CIRCUMCISION TRAY CS/24.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773482 SKLAR INSTRUMENT 5" FORCEPS-IN SKLAR CIRCUMCISION TRAY CS/24 HTD SKLAR CORP. 01194276

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA