BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAXTAMPONSPEARLPEARLSUPERPLUSUNSCNT36CT

    MDR report key: 15085398 · Received July 22, 2022

    Report

    Report Number
    1219109-2022-00298
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Report Date
    September 29, 2022
    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

    THERE IS INSUFFICIENT INFORMATION HTTPS://EMDR.FDA.GOV/EMDR/FORMREDACTION/D11.JSF#TO PERFORM A PRODUCT INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A PRODUCT INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    UNCOMFORTABLE - VAGINA [VULVOVAGINAL DISCOMFORT.] UNCOMFORTABLE - TAMPON [MEDICAL DEVICE SITE DISCOMFORT.] BRAIDED STRING SHREDDED [DEVICE BREAKAGE.] DIFFICULT TO REMOVE TAMPON [COMPLICATION OF DEVICE REMOVAL.] CASE NARRATIVE: RELATIVE REPORTED VIA E-MAIL THAT HER DAUGHTER USED TAMPON AND THE STRING SHREDDED AND EXPANDED, MAKING IT DIFFICULT TO REMOVE. NO SERIOUS INJURY REPORTED.

    Description of Event or Problem · 0

    UNCOMFORTABLE - VAGINA [VULVOVAGINAL DISCOMFORT] . UNCOMFORTABLE - TAMPON [MEDICAL DEVICE SITE DISCOMFORT] . BRAIDED STRING SHREDDED [DEVICE BREAKAGE] . DIFFICULT TO REMOVE TAMPON [COMPLICATION OF DEVICE REMOVAL] . CASE NARRATIVE: RELATIVE REPORTED VIA E-MAIL THAT HER DAUGHTER USED TAMPON AND THE STRING SHREDDED AND EXPANDED, MAKING IT DIFFICULT TO REMOVE. NO SERIOUS INJURY REPORTED.

    Description of Event or Problem · 0

    UNCOMFORTABLE - VAGINA [VULVOVAGINAL DISCOMFORT] UNCOMFORTABLE - TAMPON [MEDICAL DEVICE SITE DISCOMFORT] BRAIDED STRING SHREDDED [DEVICE BREAKAGE] DIFFICULT TO REMOVE TAMPON [COMPLICATION OF DEVICE REMOVAL] CASE NARRATIVE: RELATIVE REPORTED VIA E-MAIL THAT HER DAUGHTER USED TAMPON AND THE STRING SHREDDED AND EXPANDED, MAKING IT DIFFICULT TO REMOVE. NO SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88837 TAMPAXTAMPONSPEARLPEARLSUPERPLUSUNSCNT36CT TAMPON, MENSTRUAL, UNSCENTED - HEB HEB TAMBRANDS MANUFACTURING, INC 2136243003620001

    Patients

    Seq Age Sex Outcome Treatment
    1 Female