BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEG EXTENDER

    MDR report key: 7136685 · Received December 20, 2017

    Report

    Report Number
    2031009-2017-00039
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 6, 2017
    Report Date
    December 19, 2017
    Manufacturer
    TRIMED, INC
    Product Code
    LXH
    UDI-DI
    00842188112867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING VISUAL REVIEW OF MATERIAL BEING SENT TO HOSPITAL, IT WAS DISCOVERED THAT THE SPRING ON A PEG-XTNDR HAD CORRODED. THE NON-CONFORMING PART WAS RETURNED TO THE DISTRIBUTOR, AT WHICH POINT THE DISTRIBUTOR NOTIFIED TRIMED OF THE COMPLAINT ON (B)(6) 2017. THIS INCIDENT OCCURRED IN CHILE. THIS TYPE OF MALFUNCTION FOR THIS PART HAS AN OCCURRENCE RATE OF (B)(4) % BASED ON SALES SINCE 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915892 PEG EXTENDER PEG EXTENDER LXH TRIMED, INC PEG-XTNDR 00842188112867

    Patients

    Seq Age Sex Outcome Treatment
    1