BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUBLIX REGULAR TAMPON

    MDR report key: 258904 · Received January 13, 2000

    Report

    Report Number
    2529605-2000-00001
    Event Type
    Other
    Date Received
    January 13, 2000
    Date of Event
    November 22, 1999
    Report Date
    January 13, 2000
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    USER REPORTED ON 11/22/1999 THAT TAMPON FIBER REMAINED IN THE BODY AFTER THE TAMPON WAS REMOVED. REMAINING FIBER WAS DISCHARGED WITH DOUCHING, HOWEVER, USER REPORTED OF DEVELOPING A VAGINAL INFECTION. USER WAS ADVISED TO SEE A DOCTOR. ON 11/24/1999 THE DOCTOR DIAGNOSED THE CONDITION AS "VAGINITIS, UNSPEC" AND PRESCRIBED ANAPROX AND AMPICILLIN. USER DID NOT ADVISE FIRST QUALITY HYGIENIC, INC. UNTIL 1/12/2000 ABOUT THE DIAGNOSIS OR THE MEDICATIONS PRESCRIBED. UPON LEARNING ABOUT THE DIAGNOSIS AND MEDICATIONS ON 1/12/2000, IT WAS DETERMINED THAT THIS WAS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUBLIX REGULAR TAMPON VAGINAL TAMPON HEB FIRST QUALITY HYGIENIC, INC. OPEN END TAMPON 99HRC19

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention