BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINCO

    MDR report key: 2310041 · Received October 20, 2011

    Report

    Report Number
    1027229-2011-00004
    Event Type
    Injury
    Date Received
    October 20, 2011
    Date of Event
    October 13, 2011
    Report Date
    October 18, 2011
    Manufacturer
    WINCO MFG, LLC.
    Product Code
    FRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) OF WINCO MFG HAD AN ADDITIONAL CONVERSATION WITH A REPRESENTATIVE OF (B)(6) ON (B)(6) 2011. (B)(6) STATED THAT SHE DID NOT KNOW THAT THE MODEL OF CHAIR IN USE WAS NOT DESIGNED TO LOCK. (B)(6) ADVISED THAT THE FACILITY SHOULD PURCHASE A LONG TERM CARE CHAIR THAT HAS A LOCKING FEATURE. THE FACILITY DID NOT REPORT ANY DEFECT WITH THE CHAIR. THE FACILITY ALSO STATED THAT THE PATIENT INVOLVED WAS KNOWN TO 'SCOOT' WHILE IN THE CHAIR.

    Description of Event or Problem · 1

    (B)(6) NURSING HOME IN (B)(6) CONTACTED WINCO MFG ON (B)(6) 2011 TO REPORT AN INCIDENT WHICH RESULTED IN AN INJURY TO A PATIENT. THE PATIENT WAS SEATED IN A WINCO 6950 ELITE CARE CLINER XL CHAIR. THE STAFF MEMBER LEFT THE PATIENT UNATTENDED, AND, UPON RETURNING TO THE ROOM, FOUND THE PATIENT LAYING FACE DOWN ON THE FLOOR. THE PATIENT SUSTAINED AN INJURY TO HER FOREHEAD AND TO HER LIP. THE PATIENT CANNOT COMMUNICATE AND WAS UNABLE TO EXPLAIN WHAT HAD HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINCO ELITE CARE CLINER FRJ WINCO MFG, LLC. 6950

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other