BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAXTAMPONSPEARLFULLSIZEMIXEDUNSCNT34CT

    MDR report key: 20707406 · Received November 18, 2024

    Report

    Report Number
    1219109-2024-00383
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Report Date
    December 12, 2024
    Manufacturer
    TAMBRANDS MANUFACTURING, INC
    Product Code
    HEB
    PMA / PMN Number
    K081555
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PRODUCT INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    (PAIN INSIDE OF ME.) THE TAMPON STRING DETACHED FROM THE TAMPON WHICH LEFT THE TAMPON INSIDE- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. PAIN INSIDE OF ME. CRAMPING (THE TAMPON STRING DETACHED FROM THE TAMPON WHICH LEFT THE TAMPON INSIDE) - VAGINA [VULVOVAGINAL PAIN] . (CRAMPING), PRESSURE MY VAGINA [VULVOVAGINAL DISCOMFORT] . THE TAMPON STRING DETACHED FROM THE TAMPON [DEVICE BREAKAGE] . (PAIN INSIDE OF ME.) THE TAMPON STRING DETACHED FROM THE TAMPON WHICH LEFT THE TAMPON INSIDE [COMPLICATION OF DEVICE REMOVAL] . STOMACH PAIN [ABDOMINAL PAIN UPPER] . NAUSEA [NAUSEA] . CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON STRING DETACHED FROM THE TAMPON AND WAS LEFT INSIDE THE VAGINA. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    (PAIN INSIDE OF ME.) THE TAMPON STRING DETACHED FROM THE TAMPON WHICH LEFT THE TAMPON INSIDE- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. PAIN INSIDE OF ME. CRAMPING (THE TAMPON STRING DETACHED FROM THE TAMPON WHICH LEFT THE TAMPON INSIDE) - VAGINA [VULVOVAGINAL PAIN]. (CRAMPING), PRESSURE MY VAGINA [VULVOVAGINAL DISCOMFORT]. THE TAMPON STRING DETACHED FROM THE TAMPON [DEVICE BREAKAGE]. (PAIN INSIDE OF ME.) THE TAMPON STRING DETACHED FROM THE TAMPON WHICH LEFT THE TAMPON INSIDE [COMPLICATION OF DEVICE REMOVAL]. STOMACH PAIN [ABDOMINAL PAIN UPPER]. NAUSEA [NAUSEA]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON STRING DETACHED FROM THE TAMPON AND WAS LEFT INSIDE THE VAGINA. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112117 TAMPAXTAMPONSPEARLFULLSIZEMIXEDUNSCNT34CT TAMPON, MENSTRUAL, UNSCENTED - HEB HEB TAMBRANDS MANUFACTURING, INC 42201505T1

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female