BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASTIBELL HOSP BULK 1.2 CM

    MDR report key: 3832122 · Received May 5, 2014

    Report

    Report Number
    1422443-2014-00001
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 2, 2014
    Manufacturer
    HOLLISTER INC.
    Product Code
    FHG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE UNIT BROKE IN HALF DURING A CIRCUMCISION PROCEDURE. THE PHYSICIAN WAS TYING THE STRING AND THE PLASTIBELL POPPED OFF AND HIT THE PHYSICIAN IN THE CHEST. WHEN THE PHYSICIAN PICKED THE PLASTIBELL OFF THE FLOOR, HE NOTICED THAT THE STRING HAD TIGHTENED AROUND THE PATIENT'S PENIS, CUTTING OFF THE TIP. THE PHYSICIAN CUT OFF THE STRING FROM THE PATIENT'S PENIS. THE PATIENT HAD TO HAVE AN ADD'L SURGERY. THE HOSPITAL HAS BEEN USING THE PRODUCT SINCE NOVEMBER 2007. THE PHYSICIAN HAS BEEN USING THE PRODUCT FOR 10 YEARS. A REVIEW OF THE DEVICE HISTORY FOR THIS PARTICULAR MODEL AND LOT NUMBER WAS PERFORMED, AND NO ABNORMALITIES WERE DISCOVERED. A REVIEW OF COMPLAINT HISTORY FOR THIS PRODUCT REVEALS NO SIMILAR INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266190 PLASTIBELL HOSP BULK 1.2 CM PLASTIBELL CIRCUMCISION DEVICE FHG HOLLISTER INC. D 9212 3D06

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Hospitalization