BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECO TOUCH-FREE CATHETERIZATION SYSTEM

    MDR report key: 4181750 · Received October 13, 2014

    Report

    Report Number
    MW5038594
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    PECO MEDICAL, INC.
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECEIVED PECO TOUCH-FREE CATHETERIZATION SYSTEM, REF PK5214, LOT 1112121E, EXPIRY DATE 12//11/2014 (WHICH I UNDERSTAND IS DECEMBER 2014) BURT THE POVIDONE-IODINE SWABS ARE ALREADY EXPIRED. THE APLICARE PVP INSIDE THE URINARY CATHETER KITS ARE EXPIRED. WITHPVP-IODINE SWAB (B)(4) FROM APLICARE WITH EXPIRY DATE 11/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647166 PECO TOUCH-FREE CATHETERIZATION SYSTEM PECO TOUCH-FREE CATHETERIZATION SYSTEM EYZ PECO MEDICAL, INC. PK5214 1112121E

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other