BEUDAMED
    FDA Adverse Event Other Summary report: N

    POUCHKIN NEWBORN POUCH

    MDR report key: 2094081 · Received May 5, 2011

    Report

    Report Number
    1921454-2011-00001
    Event Type
    Other
    Date Received
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    HOLLISTER, INC.
    Product Code
    EZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BEADED ANTENNAE FROM INSIDE THE POUCHKIN NEWBORN POUCH HAD BROKEN OFF AND PUNCTURED THE STOMA. THE PART WAS REMOVED AND THE STOMA HEALED ON ITS OWN. IT IS UNK HOW THE PIECE WAS BROKEN. THIS WAS THE FIRST TIME THE HOSP HAD THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POUCHKIN NEWBORN POUCH OSTOMY POUCH EZQ HOLLISTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention