BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOP & SHOP

    MDR report key: 251847 · Received November 24, 1999

    Report

    Report Number
    2529605-1999-00004
    Event Type
    Other
    Date Received
    November 24, 1999
    Date of Event
    October 26, 1999
    Report Date
    November 24, 1999
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    USER CLAIMS TO HAVE FOUND METAL ON A TAMPON AFTER IT WAS WITHDRAWN FROM THE BODY. USER HAS NOT INDICATED THAT SHE EXPERIENCED ANY ADVERSE REACTION OR CONDITION AS A RESULT OF USING THE TAMPON. USER DID NOT SEEK MEDICAL INTERVENTION. FDA COMPLAINT COORDINATOR CONTACTED FIRST QUALITY HYGIENIC INC. ON 10/28/1999 TO DETERMINE THE TAMPONS MANUFACTURING LOCATION AND TO REQUEST FIRST QUALITY HYGIENIC, INC. SHARE THE INVESTIGATION FINDINGS WITH FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOP & SHOP SUPER PLUS VAGINAL TAMPONS HEB FIRST QUALITY HYGIENIC, INC. OPEN END TAMPON 99APC06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other