BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECLINER CHAIR

    MDR report key: 10967343 · Received December 7, 2020

    Report

    Report Number
    MW5098248
    Event Type
    Injury
    Date Received
    December 7, 2020
    Date of Event
    September 3, 2020
    Report Date
    December 4, 2020
    Manufacturer
    KNU, LLC
    Product Code
    KMN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RN ENTERED ROOM TO FIND PATIENT YELLING FOR HELP BECAUSE THE PATIENTS BKA WAS STUCK BETWEEN THE SLOT IN THE CHAIR. MAINTENANCE WAS CALLED TO THE SCENE TO REMOVE PART OF THE LEG OF THE CHAIR FOR EASIER REMOVAL WITH NO SUCCESS BECAUSE PATIENTS LEG WAS STUCK BETWEEN THE METAL PART THAT ATTACHES THE LEG OF THE CHAIR. PATIENT WAS ABLE TO WIGGLE HIS LEG OUT FROM THE METAL AFTER A FEW MINUTES WITH NO OTHER INTERVENTION. OPEN ABRASION WAS NOTED UPON REMOVAL OF LIMB. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428845 RECLINER CHAIR CHAIR AND TABLE, MEDICAL KMN KNU, LLC 1207791-009.113 3146004(LOAD#)

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention