BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 3143008 · Received May 23, 2013

    Report

    Report Number
    1820334-2013-00207
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 26, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    PMA / PMN Number
    K882796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION: UNK AS LOT IS UNK. UNK AS LOT IS UNK. (B)(4). UNK AS LOT IS UNK. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PTCD WAS PERFORMED AND A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED. ON (B)(6) 2013, THE CATHETER WAS RETRIEVED FROM THE PT'S BODY. ON (B)(6) 2013, SINCE THE PT COMPLAINED STOMACH ACHE, CT WAS CONDUCTED, WHICH CONFIRMED THERE IS A FOREIGN MATTER IN THE PERITONEUM. THE FOREIGN MATTER WAS RETRIEVED ON THE SAME DAY AND PT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228049 ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention