BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAXTAMPONSRADIANTRADIANTSUPERUNSCNT16CT

    MDR report key: 16949862 · Received May 17, 2023

    Report

    Report Number
    1219109-2023-00134
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Report Date
    September 18, 2023
    Manufacturer
    TAMBRANDS MANUFACTURING, INC
    Product Code
    HEB
    PMA / PMN Number
    K110669
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 0

    NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE LOT CODE INVESTIGATION ON PQC(PRODUCT OR COMPONENT; RETAINED IN BODY), COMPLETED ON MAY 19, 2023. AN INVESTIGATION IS IN PROGRESS FOR NEWLY ADD A PQC(PRODUCT IS COMING APART, IN PIECES, SHREDDING) ON AUG 15, 2023.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE LOT CODE INVESTIGATION ON PQC(PRODUCT OR COMPONENT; RETAINED IN BODY), COMPLETED ON MAY 19,2023. AN INVESTIGATION IS IN PROGRESS FOR NEWLY ADD A PQC(PRODUCT IS COMING APART, IN PIECES, SHREDDING) ON AUG 15,2023.

    Description of Event or Problem · 0

    PART OF THE TAMPON REMAINED INSIDE [THE BODY]- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. PART OF THE TAMPON REMAINED INSIDE [THE BODY] [DEVICE BREAKAGE] . PART OF THE TAMPON REMAINED INSIDE [THE BODY] WHEN CHANGING [COMPLICATION OF DEVICE REMOVAL]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON REMAINED INSIDE THE BODY. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    PART OF THE TAMPON REMAINED INSIDE [THE BODY]- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. PART OF THE TAMPON REMAINED INSIDE [THE BODY] [DEVICE BREAKAGE]. PART OF THE TAMPON REMAINED INSIDE [THE BODY] WHEN CHANGING [COMPLICATION OF DEVICE REMOVAL]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON REMAINED INSIDE THE BODY. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    PART OF THE TAMPON REMAINED INSIDE [THE BODY]- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. PART OF THE TAMPON REMAINED INSIDE [THE BODY] [DEVICE BREAKAGE]. PART OF THE TAMPON REMAINED INSIDE [THE BODY] WHEN CHANGING [COMPLICATION OF DEVICE REMOVAL] . CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON REMAINED INSIDE THE BODY. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    PART OF THE TAMPON REMAINED INSIDE [THE BODY]- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. PART OF THE TAMPON REMAINED INSIDE [THE BODY] [DEVICE BREAKAGE]. PART OF THE TAMPON REMAINED INSIDE [THE BODY] WHEN CHANGING [COMPLICATION OF DEVICE REMOVAL]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON REMAINED INSIDE THE BODY. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381302 TAMPAXTAMPONSRADIANTRADIANTSUPERUNSCNT16CT TAMPON, MENSTRUAL, UNSCENTED - HEB HEB TAMBRANDS MANUFACTURING, INC 2104208000 V1

    Patients

    Seq Age Sex Outcome Treatment
    1 Female