BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IGIA FINALLY GONE HAIR REMOVAL SYSTEM

    MDR report key: 686240 · Received February 2, 2005

    Report

    Report Number
    MW1038159
    Event Type
    Injury
    Date Received
    February 2, 2005
    Date of Event
    September 28, 2004
    Report Date
    February 2, 2005
    Manufacturer
    TACTICA INTERNATIONAL
    Product Code
    KCX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT WAS BORN WITH CAUDAL REGRESSION SYNDROME WHICH IS A DEFORMITY IN THE LOWER SPINE WHERE HER SACRUM AND TAIL BONE DID NOT DEVELOP. BECAUSE OF THIS DEFORMITY, HER NERVES IN HER LOWER BODY MAY BE AFFECTED. THIS CAUSED HER TO HAVE BILATERAL CLUB FEET WHICH HAVE BEEN CASTED FOR THE LAST COUPLE MONTHS AND MAY REQUIRE SURGERY. HER ABILITY TO WALK IS UNKNOWN AT THIS TIME. IN ADDITION, THIS SYNDROME CAN CAUSE PROPLEMS WITH HER URINARY TRACT AND BOWEL MOVEMENTS. THE MAJORITY OF HER PROBLEMS WILL NOT BE KNOWN UNTIL SHE GETS A LITTLE OLDER. SHE HAS REFLUX OF URINE FROM HER BLADDER BACK INTO HER KIDNEYS. SHE IS ON A LOW DOSE OF AMOXICILLIN TO PREVENT ANY BLADDER OR KIDNEY INFECTIONS. IN ADDITION TO THE CAUDAL REGRESSION, SHE HAS A MODERATE HEARING LOSS IN HER RIGHT EAR WHICH WILL REQUIRE A HEARING AID, SHE IS MISSING ONE RIB, AND HAD A SMALL HOLE IN HER HEART. CAUDAL REGRESSION SYNDROME AND THESE OTHER DEFORMITIES ARE NOT CAUSED BY GENETICS AND DOCTORS DO NOT KNOW THE CAUSE. SINCE THE EAR DRUMS, ORGANS AND SPINAL CORD ARE FORMED DURING THE FIRST COUPLE MONTHS OF GESTATION, I CAN NOT HELP BUT WONDER IF SOME OF HER PROBLEMS ARE RELATED TO ME USING THE IGIA FINALLY GONE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IGIA FINALLY GONE HAIR REMOVAL SYSTEM PERMANENT HAIR REMOVAL KCX TACTICA INTERNATIONAL AT6758 *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Congenital Anomaly| R| S