BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW

    MDR report key: 8622579 · Received May 19, 2019

    Report

    Report Number
    3014498534-2019-10001
    Event Type
    Injury
    Date Received
    May 19, 2019
    Date of Event
    February 17, 2019
    Report Date
    April 5, 2019
    Manufacturer
    THAI HASO LTD.
    Product Code
    EYQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD A RED RASH ON HER SKIN AND ITCHY PALMS AND FEET AND SOUGHT MEDICAL TREATMENT. CUSTOMER CLAIMS THAT HER RASH WAS AN ANAPHYLACTIC ALLERGIC REACTION TO LATEX THAT WAS CAUSED AFTER WEARING WILLOW INCONTINENCE UNDERWEAR FOR 16 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416015 WILLOW INCONTINENCE UNDERWEAR EYQ THAI HASO LTD. 855038008128

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other