BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE RECLINER

    MDR report key: 3637014 · Received February 17, 2014

    Report

    Report Number
    1027229-2014-00001
    Event Type
    Injury
    Date Received
    February 17, 2014
    Date of Event
    February 16, 2014
    Report Date
    February 17, 2014
    Manufacturer
    WINCO MFG LLC
    Product Code
    FRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CAREGIVER WAS ADVISED THAT THE TABLE WAS NOT TO BE USED AS A RESTRAINT NOR WAS THE PT TO BE LEFT ALONE IN THE RECLINER.

    Description of Event or Problem · 1

    AT APPROPRIATELY 12:30 PM, MONDAY (B)(6) 2014, WINCO RECEIVED A CALL FROM (B)(6), STATING THAT HER DAUGHTER FELL FROM HER WINCO LIFE-CARE RECLINER. (B)(6) STATED THAT SHORTLY AFTER LEAVING THE ROOM TO ATTEND TO THE OTHER CHILDREN, SHE HEARD A CALL FROM HER DAUGHTER. WHEN (B)(6) RE-ENTER THE ROOM SHE NOTICED THAT HER DAUGHTER WHO SITTING IN THE RECLINER THE ENTIRE DAY AND WHO HAS CEREBRAL PALSY WAS NOW ON THE FLOOR. SHE STATED THAT SHE DIDN'T KNOW HOW SHE FELL OUT OF THE RECLINER BUT WAS GUESSING THAT HER DAUGHTER CLIMBED OVER THE TABLE. SHE ALSO STATED THAT THE TABLE WAS PUSHED OFF OF THE RECLINER AND WASN'T SURE HOW IT CAME OFF. THE DAUGHTER WAS TRANSPORTED TO THE HOSP WHERE SHE WAS DIAGNOSED WITH A CONCUSSION. (B)(6) ALSO STATED THAT HER DAUGHTER'S SEIZURE STARTED UP AGAIN SINCE THE FALL, AFTER A 2 YEAR LAPSE. DAUGHTER WAS NOT ADMITTED TO HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99936 LIFECARE RECLINER GERIATRIC RECLINER FRJ WINCO MFG LLC 5851 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization