BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAXTAMPONSPEARLPEARLREGNOR

    MDR report key: 11125740 · Received January 6, 2021

    Report

    Report Number
    1219109-2021-00008
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Report Date
    December 14, 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

    INITIAL RECEIPT DATE OF CONSUMER REPORT CORRECTED TO 02-DEC-2020. PRODUCT CORRECTED TO TAMPAX/TAMPONS/PEARL/PEARL/REGULAR-NORMAL. THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.

    Description of Event or Problem · 0

    PULLED OUT A CHUNK OF SOMETHING BLUE FROM INSIDE VAGINA, PIECES STUCK INSIDE ME [FOREIGN BODY IN REPRODUCTIVE TRACT] PAIN-VAGINA [VULVOVAGINAL PAIN] INSERTED TAMPON... FELT PAIN [MEDICAL DEVICE SITE PAIN] BURNING-VAGINA [VULVOVAGINAL BURNING SENSATION] TAMPON WAS CRUMBLY [DEVICE BREAKAGE] TAMPON WAS BLUE, NO COTTON ON THE DEFECTED TAMPON AT ALL [DEVICE PHYSICAL PROPERTY ISSUE] CONSUMER SENT EMAIL STATING SHE REMOVED THE TAMPON AND IT WAS CRUMBLY AND BLUE. SHE OPENED THE LAST TAMPON FROM THAT BATCH, AND FOUND IT WAS BLUE AND CRUMBLED UPON OPENING. SHE REPORTED THERE WAS NO COTTON ON THE DEFECTIVE TAMPON AT ALL. NO SERIOUS INJURY REPORTED.

    Additional Manufacturer Narrative · 1

    THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    PULLED OUT A CHUNK OF SOMETHING BLUE FROM INSIDE VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. PAIN-VAGINA [VULVOVAGINAL PAIN]. INSERTED TAMPON. FELT PAIN [MEDICAL DEVICE SITE PAIN]. BURNING-VAGINA [VULVOVAGINAL BURNING SENSATION]. TAMPON WAS CRUMBLY [DEVICE BREAKAGE]. TAMPON WAS BLUE, NO COTTON ON THE DEFECTED TAMPON AT ALL [DEVICE PHYSICAL PROPERTY ISSUE]. CASE DESCRIPTION: CONSUMER SENT EMAIL STATING SHE REMOVED THE TAMPON AND IT WAS CRUMBLY AND BLUE. SHE OPENED THE LAST TAMPON FROM THAT BATCH, AND FOUND IT WAS BLUE AND CRUMBLED UPON OPENING. SHE REPORTED THERE WAS NO COTTON ON THE DEFECTIVE TAMPON AT ALL. NO SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24564 TAMPAXTAMPONSPEARLPEARLREGNOR TAMPON, MENSTRUAL, UNSCENTED HEB TAMBRANDS MANUFACTURING, INC NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1