BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L.TAMPONSORGCOTTONPLASTICREG+SUPERNONDO30CT

    MDR report key: 11454813 · Received March 10, 2021

    Report

    Report Number
    1219109-2021-00080
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Report Date
    February 9, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    LOT CODE INVESTIGATION RESULTS ON 25-MAR-2021 SHOWED NO FAILURE IDENTIFIED.

    Description of Event or Problem · 0

    SKINNY PART OF APPLICATOR.. INSERTED INTO VAGINA, FOREIGN BODY IN REPRODUCTIVE TRACT. SHARP PAIN/POKING FEELING - VAGINA , VULVOVAGINAL PAIN. VAGINA SHARP PAIN/POKING FEELING - TAMPON APPLICATOR, MEDICAL DEVICE SITE PAIN. SKINNY PART OF APPLICATOR DISLODGED AND INSERTED INTO VAGINA WITH TAMPON, DEVICE DEPLOYMENT ISSUE. CASE DESCRIPTION: CONSUMER REPORTED VIA SOCIAL MEDIA THAT THE PART OF THE APPLICATOR THAT PUSHES THE TAMPON IN BECAME DISLODGED AND INSERTED INTO HER VAGINA. NO SERIOUS INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    SKINNY PART OF APPLICATOR...INSERTED INTO VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. SHARP PAIN/POKING FEELING: VAGINA [VULVOVAGINAL PAIN]. VAGINA SHARP PAIN/POKING FEELING: TAMPON APPLICATOR [MEDICAL DEVICE SITE PAIN]. SKINNY PART OF APPLICATOR DISLODGED AND INSERTED INTO VAGINA WITH TAMPON [DEVICE DEPLOYMENT ISSUE]. CONSUMER REPORTED VIA SOCIAL MEDIA THAT THE PART OF THE APPLICATOR THAT PUSHES THE TAMPON IN BECAME DISLODGED AND INSERTED INTO HER VAGINA. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349771 L.TAMPONSORGCOTTONPLASTICREG+SUPERNONDO30CT TAMPON, MENSTRUAL, UNSCENTED HEB TAMBRANDS MANUFACTURING, INC 0141243066W 09 36

    Patients

    Seq Age Sex Outcome Treatment
    1