BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O.B. APPLICATOR TAMPON

    MDR report key: 216857 · Received March 29, 1999

    Report

    Report Number
    9680761-1999-00001
    Event Type
    Injury
    Date Received
    March 29, 1999
    Date of Event
    December 10, 1998
    Report Date
    February 23, 1999
    Manufacturer
    JOHNSON AND JOHNSON, S.A.
    Product Code
    HEB
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A 14 YEAR OLD CONSUMER BECAME ILL WHILE MENSTRUATING AND WAS ADMITTED TO THE HOSP FOR 3 DAYS. CONSUMER WAS READMITTED TO HOSP ON 12/25/1999 AFTER DEVELOPING PHLEBITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O.B. APPLICATOR TAMPON MENSTRUAL - TAMPON HEB JOHNSON AND JOHNSON, S.A. SUPER PLUS 120583

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R