BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPON MENSTRUAL, UNSCENTED

    MDR report key: 20633154 · Received November 7, 2024

    Report

    Report Number
    3014829931-2024-00002
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 17, 2024
    Report Date
    November 7, 2024
    Manufacturer
    ALBAAD MASSUOT YITZHAK LTD
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOR THIS INVESTIGATION, THE SPECIFIC LOT, WAS REPORTED BY THE CONSUMER. THEREFORE, A CASE OF PRODUCT AT THE DISTRIBUTION CENTER WAS REVIEWED BY BRAND QA FOR QUALITY AND 0 DEFECTS WERE FOUND. IN ADDITION, THE CONTRACT MANUFACTURER HAS LAUNCHED AN INVESTIGATION INTO THIS DEFECT AND WILL REVIEW PRODUCTION RECORDS AND RETAIN SAMPLES AND WILL WORK TO IDENTIFY A ROOT CAUSE. IF ANY ISSUES ARE IDENTIFIED BY THE CONTRACT MANUFACTURER WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT THEN THE MEDWATCH WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    ON 18-OCT-2024, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA A CONSUMER. ON AN UNSPECIFIED DATE, THE CONSUMER APPLIED A TAMPON FOR MENSES. ON (B)(6) 2024, WHILE THE CONSUMER WAS SWITCHING OUT THE TAMPON, SHE HEARD A CRACK AND FELT A PINCH. SHE ATTEMPTED TO PULL OUT THE PLASTIC APPLICATOR AND ONLY PULLED OUT HALF. THE REST REMAINED INSIDE HER. AFTER A FEW MINUTES OF TRYING TO GET THE REST OF THE APPLICATOR OUT, SHE WAS SUCCESSFUL. IT WAS EXTREMELY PAINFUL, AND THE PLASTIC WAS BROKEN, RIDGED, AND HAD SHARP EDGES. SHE NOTED SHE HAD NOT HAD AN EXPERIENCE LIKE THIS ONE BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876744 TAMPON MENSTRUAL, UNSCENTED TAMPON MENSTRUAL, UNSCENTED HEB ALBAAD MASSUOT YITZHAK LTD 3079.17.14

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other