BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASTIBELL CIRCUMCISION DEVICE

    MDR report key: 473788 · Received July 18, 2003

    Report

    Report Number
    1921454-2003-00001
    Event Type
    Injury
    Date Received
    July 18, 2003
    Date of Event
    March 4, 2002
    Report Date
    July 14, 2003
    Manufacturer
    HOLLISTER, INC.
    Product Code
    FHG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT DURING A CIRCUMCISION PROCEDURE WHERE A PLASTIBELL WAS USED THERE WAS A SEVERING OF THE PT'S URETHRA AND A SLICING OF THE PT'S "GLAND".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASTIBELL CIRCUMCISION DEVICE CIRCUMCISION DEVICE FHG HOLLISTER, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other