BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLLISTER

    MDR report key: 1726772 · Received June 11, 2010

    Report

    Report Number
    MW5016362
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    January 24, 2010
    Report Date
    June 11, 2010
    Manufacturer
    BRIGGS
    Product Code
    FHG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BABY HAD A PLASTIBELL 1.4 CIRCUMCISION PERFORMED ON (B) (6) 2010 BY DR (B) (6) OB/GYN. DR (B) (6), ATTENDING FAMILY PHYSICIAN SAW PT IN THE OFFICE AS F/U ROUTINE VISIT AND FOUND THE RING WAS BELOW THE GLANS. THE GLANS HAD A BLUEISH HUE. BABY WAS SENT TO A HOSP TO SEE A UROLOGIST FOR RING REMOVAL - A RING CUTTER WAS USED TO REMOVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLLISTER PLASTIBELL CIRCUMCISION DEVICE FHG BRIGGS 9234 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Required Intervention