BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUTURO (TM) MOISTURE CONTROL KNEE

    MDR report key: 3853515 · Received May 30, 2014

    Report

    Report Number
    2110898-2014-00035
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    WINNING INDUSTRIAL CO. LTD
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING NAME AND ADDRESS SHOULD BE CONSIDERED CONFIDENTIAL.

    Description of Event or Problem · 1

    PURCHASING FUTURO MOISTURE CONTROL KNEE SUPPORT SIZE MEDIUM (B)(4) APPROXIMATELY TWO WEEKS AGO. WORE THE PRODUCT FOR 24 HOURS, OVERNIGHT APPROXIMATELY 1 1/2 WEEKS AGO. HE NOTICED MANY RED DOTS AND WAS ITCHING AFTER HE REMOVED THE KNEE SUPPORT. CUSTOMER STATED, "THEN THE RASH SPREAD ALL OVER." HE WENT TO THE EMERGENCY ROOM AT (B)(6) THE FIRST TIME ON (B)(6) 2014. HE WAS PRESCRIBED PREDNISONE, WHICH DID NOT WORK. HE WENT IN AGAIN ON (B)(6) 2014 BECAUSE THE "RATH" WAS WORSE AND SPREAD TO HIS OTHER LEG. THE DOCTOR GAVE HIM A LOTION. CUSTOMER STATED HE DOES NOT REMEMBER WHICH LOTION OR THE NAME BECAUSE IT DID NOT WORK. WENT IN THIS MORNING (B)(6) 2014 AND DOCTOR PRESCRIBED THE FOLLOWING: (CUSTOMER SPELLED THE NAMES) DICLOXACILLIN 250 MILLIGRAM CAPSULES. INSTRUCTIONS: TAKE 2 CAPSULES BY MOUTH TWICE PER DAY AND UP TO 10 DAYS. CLOBETASOL PROPIONATE. PRESCRIBED TWO TUBES. INSTRUCTIONS: TWICE DAILY, ONCE IN THE MORNING AND ONCE AT NIGHT. THEN HAD TO GET A SHOT THIS MORNING DUE TO HIS ARM ALL THE WAY DOWN TO HIS WRIST WAS RED AND THEY TOLD HIM IT WAS AN INFECTION (HE DID NOT SPECIFY IF THIS WAS RELATED TO USE THE KNEE SUPPORT). THE SHOT WAS TO GET RID OF THE INFECTION, BUT CUSTOMER DOES NOT RECALL WHAT IT WAS CALLED. THE MAIN POINT IS THAT HE REALLY LIKED THE PRODUCT AND HOW COMFORTABLE IT WAS BEFORE NOTICING THE "RASH". HE DID FIND OUT HE IS ALLERGIC TO NEOPRENE. YEARS AGO HE WORE A NICOTINE PATCH THAT HAD NEOPRENE IN IT AND DEVELOPED A RASH, AS WELL. ALLERGIC REACTION PER DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318173 FUTURO (TM) MOISTURE CONTROL KNEE 890.3475 LIMB ORTHOSIS IQI WINNING INDUSTRIAL CO. LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK