BEUDAMED
    FDA Adverse Event Other Summary report: N

    POUCHKINS NEW BORN OSTOMY POUCH

    MDR report key: 1356401 · Received April 3, 2009

    Report

    Report Number
    1921454-2009-00001
    Event Type
    Other
    Date Received
    April 3, 2009
    Report Date
    March 31, 2009
    Manufacturer
    HOLLISTER, INC.
    Product Code
    EZQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE 'ANTENNAS' ARE APPROXIMATELY 1.5" LONG AND ARE LOCATED INSIDE THE BOTTOM OF THE POUCH. THEY ARE PART OF THE MOLDED DRAIN VALVE ASSEMBLY AND FUNCTION TO KEEP THE SIDES OF THE DRAINAGE AREA OF THE POUCH FROM STICKING. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LACERATION WAS NOTED ON THE BODY OF INFANT. IT WAS ALSO REPORTED THAT BOTH "VALVE ANTENNAS" OF THE DEVICE WERE BROKEN OFF. ONE "ANTENNA" PIECE WAS FOUND, HOWEVER, THE SECOND "ANTENNA" PIECE WAS NOT ABLE TO BE LOCATED. EXPLORATORY SURGERY WAS PERFORMED DUE TO UNCERTAINTY AS TO WHETHER THE REMAINING MISSING PIECE MAY HAVE LODGED IN THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POUCHKINS NEW BORN OSTOMY POUCH OSTOMY POUCH EZQ HOLLISTER, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention