BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASTIBELL HOSP BULK 1.2 CM

    MDR report key: 1373745 · Received May 1, 2009

    Report

    Report Number
    1219232-2009-00003
    Event Type
    Injury
    Date Received
    May 1, 2009
    Date of Event
    February 1, 2009
    Report Date
    April 30, 2009
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    FHG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN NOTED EXCESSIVE BLEEDING AFTER THE COMPLETION OF THE CIRCUMCISION PROCEDURE AND FOUND THAT THE PLASTIBELL WAS BROKEN IN HALF. UNIT WAS REMOVED AND PRESSURE WAS APPLIED TO CONTROL THE BLEEDING. PATIENT SUTURED AND RELEASED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASTIBELL HOSP BULK 1.2 CM PLASTIBELL CIRCUMCISION DEVICE FHG HOLLISTER INCORPORATED D 9212 8I01

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention