BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURP CBI TUBING

    MDR report key: 8546721 · Received April 23, 2019

    Report

    Report Number
    MW5086144
    Event Type
    Injury
    Date Received
    April 23, 2019
    Date of Event
    April 14, 2019
    Report Date
    April 19, 2019
    Manufacturer
    UNK
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TIP OF THE SEP6 WIRE THAT IS USED WITH THE PENUMBRA CAT6 THROMBECTOMY CATHETER BROKE OFF DURING USE IN PATIENT. THE BROKEN TIP WAS SNARED AND RETRIEVED OUT OF PATIENT. NO FOREIGN BODY WAS LEFT IN PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335921 TURP CBI TUBING CATHETER, UROLOGICAL KOD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention