BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 3230717 · Received July 17, 2013

    Report

    Report Number
    9611594-2013-00072
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 22, 2013
    Product Code
    HEB
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCUMENT AND RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. DOCUMENTATION ASSESSED INCLUDES: MANUFACTURING, QUALITY AUDIT, PRODUCTION, RAW MATERIAL AND DEVICE HISTORY RECORDS. THIS ASSESSMENT FOUND NO ANOMALIES THAT MAY HAVE ATTRIBUTED TO THE REPORTED ISSUE. COMPLAINT SAMPLE WAS RECEIVED AND EVALUATION IS ONGOING. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT A PIECE OF THE APPLICATOR BROKE OFF AND REMAINED WITHIN IN HER VAGINA. SHE STATED THAT SHE INSERTED A TAMPON ON (B)(6) 2013. ON (B)(6) 2013, SHE INDICATED WHILE HAVING INTERCOURSE WITH HER PARTNER, HE DISCOVERED THE PIECE OF APPLICATOR LODGED IN HER VAGINA. SHE VISITED HER DOCTOR AND HE ENSURED THERE WERE NO REMAINING PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331721 U BY KOTEX SLEEK TAMPON HEB REGULAR AA233502A

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR