BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINCO

    MDR report key: 1938169 · Received December 17, 2010

    Report

    Report Number
    1027229-2010-00002
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 17, 2010
    Manufacturer
    WINCO MFG LLC
    Product Code
    FRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WINCO MADE INITIAL CONTACT WITH THE REPORTING FACILITY ON (B)(4) 2010. WE RECEIVED A REPLY PHONE CALL FROM THE REPORTING FACILITY ON (B)(4) 2010 WHICH PROVIDED UPDATED CONTACT INFO AND WHEN A REPLY COULD BE EXPECTED. THE REPORTING FACILITY CONTACTED WINCO ON (B)(4) 2010 TO VERIFY THAT THE INJURY TO THE PT WAS NOT WITNESSED AND IT WAS ASSUMED THAT THE PT'S LEG WAS CAUGHT IN THE MECHANISM OF THE CHAIR. THEY ALSO STATED THAT THE CHAIR HAD BEEN QUARANTINED. ALL AVAILABLE INFO INDICATES THAT THIS EVENT IS THE RESULT OF PRODUCT MISUSE AND THERE IS NO EVIDENCE OF ANY MALFUNCTION OF THE CHAIR.

    Description of Event or Problem · 1

    PT'S SOCK WAS REMOVED FROM LEFT FOOT TO FIND POOLED BLOOD AND A DEEP GASH TO THE TOP OF THE FOOT, TENDONS EXPOSED. FURTHER INSPECTION REVEALED ANOTHER GASH TO LEFT CALF. EVENT WAS NOT WITNESSED BUT IT IS ASSUMED THAT THE PT GOT THEIR LEG CAUGHT IN THE MECHANISM OF THE CHAIR BECAUSE THE APRON WAS LOOSE ON THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINCO DROP ARM CONVALESCENT RECLINER FRJ WINCO MFG LLC 5271

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention