BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYCARE

    MDR report key: 19280095 · Received May 9, 2024

    Report

    Report Number
    3009402404-2024-00018
    Event Type
    Injury
    Date Received
    May 9, 2024
    Report Date
    May 8, 2024
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY JOERNS HEALTHCARE , ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT WHILE MOVING THE SHIPMENT INSIDE THE BUILDING, A MALE (ONE OF PSWS) CUT HIS INDEX FINGER ON THE PLASTIC BAND HOLDING PACKAGING TOGETHER. IT REQUIRED A BAND-AID, NOT STITCHES. A 67 YR OLD FEMALE WHO WORKS IN THE ENVIRONMENTAL SERVICE DEPARTMENT STRAINED HER BACK. SHE HAD TIGHTNESS IN HER BACK AFTERWARDS. INTERNAL INCIDENT REPORTS ARE ON FILE AT FACILITY. NO INDICATION OF LOST TIME FOR EITHER. COMPLAINT #140509 WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469963 EASYCARE PATIENT BED FNL JOERNS HEALTHCARE ECS6RIL8042A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other