BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIGHN TRANS-OBTURATOR URETHRAL SUPPORT

    MDR report key: 3913667 · Received June 27, 2014

    Report

    Report Number
    MW5037050
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BARD INC
    Product Code
    OTN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PLASTIC SHEATH ON PRODUCT BROKE BEFORE IT WAS SUPPOSED TO. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376437 ALIGHN TRANS-OBTURATOR URETHRAL SUPPORT HALO OTN BARD INC REF# BRD500HL HUYC1179

    Patients

    Seq Age Sex Outcome Treatment
    1