BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUTURO ULTRA SHEER KNEE HIGHS FOR WOMEN

    MDR report key: 11860233 · Received May 20, 2021

    Report

    Report Number
    2110898-2021-00034
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    February 19, 2021
    Report Date
    May 20, 2021
    Manufacturer
    3M HEALTH CARE
    Product Code
    DWL
    UDI-DI
    00051131215900
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY, RACE: INFORMATION NOT PROVIDED. THE PRODUCT DOES NOT HAVE AN EXPIRATION DATE. NO SAMPLE HAS BEEN RETURNED TO 3M FOR EVALUATION. ROOT CAUSE OF REPORTED ISSUE COULD NOT BE ESTABLISHED. COMPLAINT HISTORY WAS REVIEWED OVER THE PAST 24 MONTHS FOR THE PRODUCTS GLOBAL SALES CODE (GSC) OF EAG AND THE REPORTED FAILURE. NO TRENDS WERE OBSERVED, END OF REPORT.

    Description of Event or Problem · 1

    A FEMALE CUSTOMER (AGE UNSPECIFIED) ALLEGED THE FUTURO¿ ULTRA SHEER KNEE CAUSED A RAISED, RED, ITCHY RASH ALL OVER HER BODY (EXCEPT FOR HER FACE AND BACK) AFTER 2 WEEKS OF USE. SHE PURCHASED THE PRODUCT IN (B)(6) 2021. SHE WORE THE PRODUCT FROM 6AM TO 10 PM DAILY FOR ABOUT 2 WEEKS. DURING THE TWO WEEKS PERIOD SHE WORE THE PRODUCT, SHE RINSED THE PRODUCT, BUT SHE DID NOT WASH WITH SOAP. SHE ALLEGED SHE HAD DIFFICULTY SLEEPING BECAUSE THE ITCHING WAS VERY BAD. HER DOCTOR PRESCRIBED MEDROL FOR ITCHING (DATE UNSPECIFIED). THE ALLEGED INJURY RESOLVED 5 DAYS AFTER SHE STARTED USING THE PRESCRIBED MEDICATION. SHE REPORTED THAT 1.5 YEARS AGO SHE HAD A SIMILAR TYPE OF BODY RASH AFTER SHE UNDERWENT A HIP REPLACEMENT SURGERY (THE DOCTOR USED ADHESIVE SUTURES TO CLOSE THE INCISION). NO ALLERGIES OR MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751149 FUTURO ULTRA SHEER KNEE HIGHS FOR WOMEN MEDICAL SUPPORT STOCKING DWL 3M HEALTH CARE N/A 20268E 00051131215900

    Patients

    Seq Age Sex Outcome Treatment
    1 Other