BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L.TAMPONSORGCOTTONCOMPAKREGNORNONDO

    MDR report key: 9855108 · Received March 19, 2020

    Report

    Report Number
    9615100-2020-00004
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Report Date
    February 21, 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. 04-AUG-2020 ADDITIONAL 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:1216894. 04-AUG-2020, ADDITIONAL PRODUCT INVESTIGATION RESULTS: NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.

    Description of Event or Problem · 0

    COTTON REMAINED LODGED INSIDE VAGINAL CANAL - TAMPON [FOREIGN BODY IN REPRODUCTIVE TRACT]. WHILE REMOVING THEM THE TAMPON COULD COME OUT IN PIECES (FELL APART) [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER REPORTED VIA E-MAIL THAT WHEN SHE REMOVED THE TAMPONS THEY COULD COME OUT IN PIECES (FELL APART). NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    COTTON REMAINED LODGED INSIDE VAGINAL CANAL - TAMPON [FOREIGN BODY IN REPRODUCTIVE TRACT]. WHILE REMOVING THEM THE TAMPON COULD COME OUT IN PIECES (FELL APART) [DEVICE BREAKAGE]. CONSUMER REPORTED VIA E-MAIL THAT WHEN SHE REMOVED THE TAMPONS THEY COULD COME OUT IN PIECES (FELL APART). NO SERIOUS INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COTTON REMAINED LODGED INSIDE VAGINAL CANAL - TAMPON [FOREIGN BODY IN REPRODUCTIVE TRACT]. WHILE REMOVING THEM THE TAMPON COULD COME OUT IN PIECES (FELL APART) [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER REPORTED VIA E-MAIL THAT WHEN SHE REMOVED THE TAMPONS THEY COULD COME OUT IN PIECES (FELL APART). NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316663 L.TAMPONSORGCOTTONCOMPAKREGNORNONDO TAMPON, MENSTRUAL, UNSCENTED HEB ONTEX HYGIENEARTIKEL GMBH 21148/5960

    Patients

    Seq Age Sex Outcome Treatment
    1