BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTOSIS SLING

    MDR report key: 12744788 · Received November 3, 2021

    Report

    Report Number
    12744788
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    September 24, 2021
    Report Date
    October 5, 2021
    Manufacturer
    FCI SAS
    Product Code
    HJZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A BOX OF 3 WAS PURCHASED. THE FIRST SLING WAS BENT AND UNUSABLE. THE SECOND SLING WAS OPENED AND BROKE DURING INSERTION: THIS ONE HAD PATIENT CONTACT BUT NO PATIENT HARM. THE THIRD SLING WAS ABLE TO BE PLACED. MANUFACTURER RESPONSE FOR PTOSIS SLING SET, (BRAND NOT PROVIDED) (PER SITE REPORTER). THEY WILL SEND RETURN KIT AND ISSUE CREDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1646098 PTOSIS SLING CRUTCH, PTOSIS HJZ FCI SAS S3.1000U 2055743

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA