BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOOP OSTOMY ROD

    MDR report key: 2559791 · Received April 18, 2012

    Report

    Report Number
    2243969-2012-00025
    Event Type
    Malfunction
    Date Received
    April 18, 2012
    Date of Event
    April 12, 2011
    Report Date
    April 18, 2012
    Manufacturer
    CONVATEC
    Product Code
    EZP
    PMA / PMN Number
    K811240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SWIVEL END BREAKS INTO PIECES WHEN OPENED. NO HARM OR INJURY TO THE PT WAS REPORTED. THIS WAS DEEMED A SERIOUS MALFUNCTION BECAUSE OF THE POSSIBLE DANGER OF A BROKEN PIECE OF THE LOOP ROD FALLING INTO THE ABDOMINAL CAVITY DURING THE SURGICAL PROCEDURE WHEN THE STOMA IS TREATED WHICH COULD REQUIRE MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY. DURING A ROUTINE REVIEW OF OUR COMPLAINT CODES, WHICH INSURES THE ROBUSTNESS AND SUSTAINED PERFORMANCE OF THE COMPLAINT HANDLING PROCESS, IT WAS DISCOVERED THAT THIS COMPLAINT CODE TYPE ("BROKEN CRACKED" FOR THE LOOP OSTOMY ROD) WAS CAPTURED AS A "PRODUCT ISSUE" AND THAT, IN THIS CASE, THIS SHOULD HAVE BEEN CAPTURED AS A POTENTIALLY REPORTABLE MALFUNCTION, WHICH MAY REQUIRE MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY. THIS COMPLAINT CODE HAS SINCE BEEN UPDATED ACCORDINGLY IN OUR COMPLAINT HANDLING SYSTEM. A RETROSPECTIVE SEARCH OF OUR COMPLAINT RECORDS CONFIRMED THAT THIS WAS THE ONLY POTENTIALLY REPORTABLE MALFUNCTION, THAT NO OTHER PREVIOUS COMPLAINTS WERE CAPTURED AS A "PRODUCT ISSUE" REPORTED TO THE FDA ON APRIL 18, 2012. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOP OSTOMY ROD COLOSTOMY ROD EZP CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening