BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOURED SLING

    MDR report key: 41405 · Received September 30, 1996

    Report

    Report Number
    1525712-1996-00012
    Event Type
    Injury
    Date Received
    September 30, 1996
    Date of Event
    August 17, 1996
    Report Date
    August 28, 1996
    Manufacturer
    INVACARE CORPORATION
    Product Code
    FSA
    Removal / Correction Number
    21 USC 360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MFR RECEIVED A REPORT OF A PT FALLING FROM A LIFT AS A RESULT OF A SLING BECOMING UNHOOKED DURING TRANSFER. THE PT ALLEGEDLY SUSTAINED A BROKEN ARM AND LEG. THE LIFT INVOLVED HAS BEEN IN SERVICE FOR OVER 7 YRS AND NO MALFUNCTION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOURED SLING PATIENT LIFT ACCESSORY FSA INVACARE CORPORATION 9042, 9070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention