BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLLISTER

    MDR report key: 1726769 · Received June 11, 2010

    Report

    Report Number
    MW5016360
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    June 7, 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 1.3 CIRCUMCISION PERFORMED ON (B) (6) 2010 BY DR (B) (6) OB/GYN. MOTHER CALLED ON (B) (6) 2010 STATING THAT THE RING HAD SLIPPED DOWN BELOW THE GLANS. BABY SEEN AT THE HOSP OB DEPT WHERE DR (B) (6) REMOVED THE RING WITH VASELINE AND TRACTION. (DR (B) (6) HAD USED THESE PRODUCTS FOR YEARS WITHOUT ANY ISSUES - WE CONTACTED MFR TO ASK IF THEY HAD MADE ANY PRODUCT CHANGES - THEY SAID NO).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLLISTER PLASTIBELL CIRCUMCISION DEVICE FHG BRIGGS 9233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA Required Intervention