BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_COMMUNICATION_PRODUCT

    MDR report key: 12564393 · Received October 1, 2021

    Report

    Report Number
    0002031963-2021-00016
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    May 28, 2021
    Report Date
    October 1, 2021
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    GDC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED A PATIENT "WAS IN THE MIDDLE OF A PLANNED LAPAROSCOPIC SIGMOID COLECTOMY AT THE (B)(6) WHEN THE OPERATING BED BROKE. THE PROCEDURE WAS CONDUCTED BY DR. (B)(6). AS A RESULT OF THE BROKEN BED INCIDENT, [THE PATIENT] SUSTAINED BODILY INJURIES AND RECEIVED TREATMENT." STRYKER HAS NOT RECEIVED ANY FURTHER INFORMATION REGARDING THE EXTENT OF THE PATIENT'S INJURIES, PATIENT TREATMENT, DEVICE IDENTIFICATION OR PERFORMANCE. IF ANY FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE THE OPERATING BED BROKE AND THE PATIENT SUSTAINED BODILY INJURIES AND RECEIVED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461341 UNKNOWN_COMMUNICATION_PRODUCT TABLE, OPERATING-ROOM, ELECTRICAL GDC STRYKER-COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other