BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTERG ANTI-GRAVITY TREADMILL

    MDR report key: 2994433 · Received March 5, 2013

    Report

    Report Number
    3007033433-2013-00001
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 14, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ALTERG INC
    Product Code
    BXB
    PMA / PMN Number
    K072887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER STATEMENTS FROM CUSTOMER, MULTIPLE USES OF THE SHORTS GARMENT WERE HAPPENING BETWEEN WASH CYCLES. THE IMPACTED FACILITY HIRED SOMEONE TO COME IN AND TEST THE PH OF THE WATER. THEY ARE CONFIDENT IN THE DISINFECTING AT THE WATER TEMP THEY ARE NOW USING (NO LONGER COLD WATER) WILL RESOLVE THE ISSUE. THE SITE HAS ALSO BOUGHT MORE SHORTS GARMENTS TO ELIMINATE THE NEED FOR SHARING OF THE GARMENTS BETWEEN WASH CYCLES. ALTERG WILL EVALUATE THE LABELING INSTRUCTIONS FOR APPROPRIATE HANDLING AND USE OF SHORTS TO USERS; UPDATING INSTRUCTIONS AS APPROPRIATE. ALTERG WILL CONTINUE TO TRACK THIS ISSUE IN OUR COMPLAINT SYSTEM FOR RE-OCCURRENCE AS WELL AS EFFECTIVENESS OF ANY CHANGES IMPLEMENTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT 5 STUDENT ATHLETES CONTRACTED A STAPH INFECTION TRANSMITTED THROUGH THE SHARING OF SHORTS WHILE USING THE ALTERG ANTI-GRAVITY TREADMILL. PER THE CUSTOMER: ABOUT 5 CASES. DIAGNOSED BY A MEDICAL DOCTOR. HAPPENS WITH COLLEGE AGE FEMALE ATHLETES WHO HAVE SOME CHAFING ISSUES BETWEEN THEIR LEGS. THE STAPH MAKES THE PROBLEM A LOT WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93302 ALTERG ANTI-GRAVITY TREADMILL BXB ALTERG INC M320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other