BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHORUS

    MDR report key: 1869358 · Received October 1, 2010

    Report

    Report Number
    9611530-2010-00069
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MFG BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, ARJO INC, (B)(4). ADDITIONAL INF WIL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER ON THE 2010-09-23: (YYY/MM/DD). RESIDENT BEING TRANSFERRED FROM A BED TO A WHEELCHAIR WAS LIFTED TO A STANDING POSITION. THE RESIDENT STEPPED BACKWARDS OFF THE FOOTBOARD FALLING AND TWISTING HER ANKLE. THE RESIDENT WAS INJURED RECEIVING AN ACUTE FRACTURE OF THE MEDIAL MALLEOLUS (LEFT). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHORUS LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB KKA5010

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR