BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC TIEMANN CH14

    MDR report key: 3181408 · Received June 14, 2013

    Report

    Report Number
    3009632672-2013-00010
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    October 10, 2011
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    KOD
    PMA / PMN Number
    K896750
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUBMISSION IS BEING MADE AFTER AN ACQUISITION AND INTERNAL AUDIT OF WELLSPECT HEALTHCARE. EXAMINATION OF BATCH DOCUMENTATION SHOWS THAT THE LOT REGISTERED IN THE COMPLAINT, (B)(4) WAS PACKAGED 2011-06-08. THE LOT WHICH SHOULD HAVE BEEN IN THE BOX, (B)(4) WAS PACKAGED 2011-01-24 AND 25, SO IT DOESN'T SEEM LIKELY THAT THE MIX UP HAPPENED DURING MANUFACTURING. THERE HAS PROBABLY BEEN A REPACKAGING SOMEWHERE.

    Description of Event or Problem · 1

    IN A BOX LABELED REF 9014 (CATHETER WITH STRAIGHT TIP) THERE IS AN ALU BAG LABELED 9614 (CATHETER WITH BENT TIP). A MALE USER USED A CATHETER WITH A BENT TIP AND HAD A BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272006 LOFRIC TIEMANN CH14 CATHETER UROLOGICAL, KOD KOD WELLSPECT HEALTHCARE 9614 88529

    Patients

    Seq Age Sex Outcome Treatment
    1 Other