BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAALT

    MDR report key: 9720793 · Received February 18, 2020

    Report

    Report Number
    3014276660-2020-20059
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 15, 2020
    Report Date
    February 11, 2020
    Manufacturer
    SAALT, LLC
    Product Code
    HHE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CONTACTED US ON 01/15/2020 TO EXPLAIN THAT SHE HAD GONE TO THE ER TO HAVE HER CUP REMOVED AFTER STRUGGLING TO REMOVE THE CUP FOR 3 HOURS. THE CUSTOMER ASKED IF SAALT WOULD REFUND THE PRICE OF THE CUP AND SAALT ISSUED A REIMBURSEMENT THROUGH (B)(6) ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187559 SAALT SMALL PINK HHE SAALT, LLC SMALL PINK N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention