BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAXTAMPONSPEARLCOMPAKPEARLCOMPAKREGNORNONDO36CT

    MDR report key: 12068762 · Received June 25, 2021

    Report

    Report Number
    1219109-2021-00225
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Report Date
    May 29, 2021
    Manufacturer
    TAMBRANDS MANUFACTURING, INC
    Product Code
    HEB
    PMA / PMN Number
    K133244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(6) 2021: NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.

    Description of Event or Problem · 0

    COULDN'T REMOVE TAMPON FOR AN HOUR [FOREIGN BODY IN REPRODUCTIVE TRACT]. AFTER AN HOUR OF TRYING I WAS FINALLY ABLE TO CATCH THE SMALL BIT OF STRING [COMPLICATION OF DEVICE REMOVAL]. THERE WAS ONLY A VERY SHORT STRING ON THE TAMPON AND THE OTHER HALF OF THE STRING JUST FELL OFF [DEVICE BREAKAGE]. CONSUMER REPORTED VIA E-MAIL THAT HALF THE STRING WAS NOT ATTACHED TO THE TAMPON. NO SERIOUS INJURY WAS REPORTED. LOT NUMBERS: 1089208000 V3 HU P 310321 02:27, 1021208000 V3 HU P 210121.

    Description of Event or Problem · 0

    COULDN'T REMOVE TAMPON FOR AN HOUR [FOREIGN BODY IN REPRODUCTIVE TRACT]. AFTER AN HOUR OF TRYING I WAS FINALLY ABLE TO CATCH THE SMALL BIT OF STRING [COMPLICATION OF DEVICE REMOVAL]. THERE WAS ONLY A VERY SHORT STRING ON THE TAMPON AND THE OTHER HALF OF THE STRING JUST FELL OFF [DEVICE BREAKAGE]. CONSUMER REPORTED VIA E-MAIL THAT HALF THE STRING WAS NOT ATTACHED TO THE TAMPON. NO SERIOUS INJURY WAS REPORTED. LOT NUMBERS: 1089208000 V3 HU P 310321 02:27, 1021208000 V3 HU P 210121.

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    COULDN'T REMOVE TAMPON FOR AN HOUR [FOREIGN BODY IN REPRODUCTIVE TRACT]. AFTER AN HOUR OF TRYING I WAS FINALLY ABLE TO CATCH THE SMALL BIT OF STRING [COMPLICATION OF DEVICE REMOVAL]. THERE WAS ONLY A VERY SHORT STRING ON THE TAMPON AND THE OTHER HALF OF THE STRING JUST FELL OFF [DEVICE BREAKAGE]. CONSUMER REPORTED VIA E-MAIL THAT HALF THE STRING WAS NOT ATTACHED TO THE TAMPON. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966482 TAMPAXTAMPONSPEARLCOMPAKPEARLCOMPAKREGNORNONDO36CT TAMPON, MENSTRUAL, UNSCENTED HEB TAMBRANDS MANUFACTURING, INC SEE B5 FOR COMPLETE LISTINGS

    Patients

    Seq Age Sex Outcome Treatment
    1