BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L.TAMPONSORGCOTTONCOMPAKMIXEDNONDO30CT

    MDR report key: 10276746 · Received July 15, 2020

    Report

    Report Number
    9615100-2020-00022
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Report Date
    June 18, 2020
    Manufacturer
    ONTEX HYGIENEARTIKEL GMBH
    Product Code
    HEB
    PMA / PMN Number
    K162746
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS SUBMITTED AS A MANUFACTURER REPORT, IT SHOULD HAVE BEEN SUBMITTED AS AN INITIAL IMPORTER REPORT. THE INITIAL IMPORTER IS THE PROCTER & GAMBLE CO./THE GILLETTE CO., 2 PROCTER AND GAMBLE PLZ, CINCINNATI, OH 45202. REGISTRATION NUMBER: 1216894. (B)(6) 2020 PRODUCT INVESTIGATION RESULTS: NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS SUBMITTED AS A MANUFACTURER REPORT, IT SHOULD HAVE BEEN SUBMITTED AS AN INITIAL IMPORTER REPORT. THE INITIAL IMPORTER IS THE PROCTER & GAMBLE CO./THE GILLETTE CO., 2 PROCTER AND GAMBLE PLZ., CINCINNATI, OH 45202. REGISTRATION NUMBER: (B)(4). THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION..

    Description of Event or Problem · 0

    TAMPON LEAVING REMNANTS INSIDE BODY VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPONS BREAK OFF WHEN TRYING TO PULL THEM OUT, LEAVING REMNANTS INSIDE BODY [COMPLICATION OF DEVICE REMOVAL]. TAMPONS BREAK OFF, COMING APART [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER CONTACTED VIA E-MAIL AND STATED THAT SHE'D HAD MULTIPLE TAMPONS BREAK OFF WHEN TRYING TO PULL THEM OUT AFTER USE; THE TAMPONS WERE COMING APART AND LEAVING REMNANTS INSIDE OF HER BODY. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    TAMPON LEAVING REMNANTS INSIDE BODY - VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] TAMPONS BREAK OFF WHEN TRYING TO PULL THEM OUT, LEAVING REMNANTS INSIDE BODY [COMPLICATION OF DEVICE REMOVAL]. TAMPONS BREAK OFF, COMING APART [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER CONTACTED VIA E-MAIL AND STATED THAT SHE'D HAD MULTIPLE TAMPONS BREAK OFF WHEN TRYING TO PULL THEM OUT AFTER USE; THE TAMPONS WERE COMING APART AND LEAVING REMNANTS INSIDE OF HER BODY. NO SERIOUS INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    TAMPON LEAVING REMNANTS INSIDE BODY - VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] TAMPONS BREAK OFF WHEN TRYING TO PULL THEM OUT, LEAVING REMNANTS INSIDE BODY [COMPLICATION OF DEVICE REMOVAL]. TAMPONS BREAK OFF, COMING APART [DEVICE BREAKAGE]. CONSUMER CONTACTED VIA E-MAIL AND STATED THAT SHE'D HAD MULTIPLE TAMPONS BREAK OFF WHEN TRYING TO PULL THEM OUT AFTER USE; THE TAMPONS WERE COMING APART AND LEAVING REMNANTS INSIDE OF HER BODY. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739527 L.TAMPONSORGCOTTONCOMPAKMIXEDNONDO30CT TAMPON MENSTRUAL, UNSCENTED HEB ONTEX HYGIENEARTIKEL GMBH 0059C77812

    Patients

    Seq Age Sex Outcome Treatment
    1