BEUDAMED
    FDA Adverse Event Other Summary report: N

    REASSURE OVERNIGHT

    MDR report key: 6078465 · Received November 2, 2016

    Report

    Report Number
    MW5065802
    Event Type
    Other
    Date Received
    November 2, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 25, 2016
    Manufacturer
    REASSURE
    Product Code
    EYQ
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER IS REPORTING THAT THE GEL SUBSTANCE CAN FALL OUT OF THE UNDERWEAR ON THE FLOOR WHICH CAN CAUSE THE USER TO FALL AND GET INJURED. SHE STATED THAT THIS PRODUCT IS USED FOR OLDER CONSUMERS AND POSES A SAFETY RISK. SHE STATED THAT THERE HAVE BEEN 2 INCIDENTS, SHE FELL THE FIRST TIME IT OCCURRED, BUT SHE WAS NOT INJURED SERIOUSLY. NO MEDICAL ATTENTION WAS RECEIVED. THE COMPANY WAS CONTACTED AND THEY INFORMED HER THAT THEY COULD DISCOUNT HER ORDER. SHE DECLINED THEIR OFFER BECAUSE THE PRODUCT IS UNSAFE. PURCHASE DATE: (B)(6) 2016, THIS DATE IS AN ESTIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725478 REASSURE OVERNIGHT DISPOSABLE OVERNIGHT UNDERWEAR EYQ REASSURE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other