BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLLISTER

    MDR report key: 852195 · Received May 14, 2007

    Report

    Report Number
    MW1042883
    Event Type
    Injury
    Date Received
    May 14, 2007
    Date of Event
    May 9, 2007
    Report Date
    May 14, 2007
    Manufacturer
    *
    Product Code
    FHG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD CIRCUMCISION EARLIER IN THE DAY. WHEN CHANGING DIAPER FOUND A MODERATE AMOUNT OF BLOODY DRAINAGE FROM THE CIRCUMCISION SITE. PHYSICIAN APPLIED PRESSURE BUT HAD DIFFICULTY CONTROLLING BLEEDING. HOLLISTER PLASTIBELL REMOVED. FINALLY CONTROLLED WITH SILVER NITRATE. HOSPITALIZATION EXTENDED ONE DAY. DO NOT SUSPECT LONG TERM EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLLISTER PLASTIBELL FHG * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY Hospitalization