BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELEFLEX WECK HORIZON SURGICAL CLIPS

    MDR report key: 12851957 · Received November 19, 2021

    Report

    Report Number
    MW5105484
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    May 22, 2020
    Report Date
    November 18, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHEN WILL THE FDA REQUIRE CONSENT FOR CLIP USE? HOW DARE SURGEONS BE ALLOWED TO PUT CLIPS (FOREIGN BODIES) IN PATIENTS WITHOUT THEIR KNOWLEDGE OR CONSENT. PLEASE SEE ATTACHED XRAYS. THESE FOUR PEOPLE HAVE HAD CLIP REMOVAL SURGERY AND WE STILL HAVE CLIPS IN US BECAUSE THEY ARE HARD TO FIND IN THE THYROID AREA. THEY ARE RISKY TO REMOVE ESPECIALLY THE ONES STUCK UP HIGH NEAR THE TOP OF TRACHEA AND ESOPHAGUS, SITTING ON THE ESOPHAGUS. THEY ARE PAINFUL. THE CLIPS ON THE TOP XRAY AND THE ONES REMOVED WITH ALL THE TISSUE ARE MADE BY TELEFLEX MEDICAL/WECK HORIZON CLIPS. WHAT IF THIS WAS DONE TO YOU OR YOUR FAMILY MEMBER?; (TOTURE DEVICES). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739118 TELEFLEX WECK HORIZON SURGICAL CLIPS CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL
    1739119 TELEFLEX WECK HORIZON SURGICAL CLIPS CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL
    1739120 TELEFLEX WECK HORIZON SURGICAL CLIPS CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL
    1739121 TELEFLEX WECK HORIZON SURGICAL CLIPS CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention| O| S| H| L