BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAX PEARL TAMPON, ULTRA UNSCENTED

    MDR report key: 9853112 · Received March 19, 2020

    Report

    Report Number
    1219109-2020-00018
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Report Date
    February 20, 2020
    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

    A PRODUCT INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 0

    15-JUL-2020 PRODUCT INVESTIGATION RESULTS: NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.

    Description of Event or Problem · 0

    APPLICATOR PLUNGER STUCK IN VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. THE PUSHING PART OF THE APPLICATOR HAS GOTTEN STUCK INTO THE INSERT PART THAT GOES INSIDE / PUSHING PART GETS STUCK ON THE COTTON AND GOES INSIDE WITH THE COTTON, DOES NOT COME BACK OUT WITH THE INSERT PORTION OF THE APPLICATOR [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER CONTACTED VIA E-MAIL AND STATED THAT THE PUSHING PART OF THE APPLICATOR HAD GOTTEN STUCK INTO THE INSERT PART THAT GOES INSIDE; THE PUSHING PART GOT STUCK ON THE COTTON AND WENT INSIDE WITH THE COTTON. IT DID NOT COME BACK OUT WITH THE INSERT PORTION OF THE APPLICATOR. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    APPLICATOR PLUNGER STUCK IN VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] THE PUSHING PART OF THE APPLICATOR HAS GOTTEN STUCK INTO THE INSERT PART THAT GOES INSIDE/PUSHING PART GETS STUCK ON THE COTTON AND GOES INSIDE WITH THE COTTON, DOES NOT COME BACK OUT WITH THE INSERT PORTION OF THE APPLICATOR [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER CONTACTED VIA E-MAIL AND STATED THAT THE PUSHING PART OF THE APPLICATOR HAD GOTTEN STUCK INTO THE INSERT PART THAT GOES INSIDE; THE PUSHING PART GOT STUCK ON THE COTTON AND WENT INSIDE WITH THE COTTON. IT DID NOT COME BACK OUT WITH THE INSERT PORTION OF THE APPLICATOR. NO SERIOUS INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    CONSUMER CONTACTED VIA E-MAIL AND STATED THAT THE PUSHING PART OF THE APPLICATOR HAD GOTTEN STUCK INTO THE INSERT PART THAT GOES INSIDE; THE PUSHING PART GOT STUCK ON THE COTTON AND WENT INSIDE WITH THE COTTON. IT DID NOT COME BACK OUT WITH THE INSERT PORTION OF THE APPLICATOR. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318052 TAMPAX PEARL TAMPON, ULTRA UNSCENTED TAMPON, MENSTRUAL, UNSCENTED HEB TAMBRANDS MANUFACTURING, INC 9307243043W00482

    Patients

    Seq Age Sex Outcome Treatment
    1