BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIER CARE CLINER

    MDR report key: 3202311 · Received June 12, 2013

    Report

    Report Number
    1027229-2013-00001
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    May 2, 2013
    Report Date
    June 12, 2013
    Manufacturer
    WINCO MFG, LLC
    Product Code
    FRJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A PHONE CONVERSATION BETWEEN PATTY OBER OF (B)(6) SURGERY CENTER AND WINCO'S DIRECTOR OF ENGINEERING, (B)(4), THE FOLLOWING CLARIFICATION OF THE INCIDENT WAS GIVEN: WHILE THE PT WAS SITTING IN THE CLINICAL CHAIR SHE REQUESTED THE HELP OF HER ROOMMATE TO ASSIST WITH PUTTING THE CHAIR INTO A RECLINED POSITION. THE ROOMMATE REACHED DOWN USING HER RIGHT HAND ON THE FOOTREST AND LEFT HAND GRABBING THE SCISSOR MECHANISM AND PROCEEDED TO LIFT UP. AT SOME POINT DURING THIS PROCESS, THE ROOMMATE'S LEFT INDEX FINGER APPROX 1 CENTIMETER BELOW THE DISTAL FIRST KNUCKLE WAS SEVERED. THE ROOMMATE WAS UNABLE TO DETERMINE DEFINITIVELY WHAT PART OF THE MECHANISM SEVERED HER FINGER. THERE WAS NO NURSE IN THE ROOM AT THE TIME OF THE INCIDENT. THE CLINICAL CHAIR WAS TAKEN OUT OF SERVICE DUE TO POSSIBLE LITIGATION ISSUES AND NOT DUE TO THE OPERATION AND SAFETY OF THE CHAIR.

    Description of Event or Problem · 1

    PT WAS SCHEDULED AT (B)(6) SURGERY CENTER FOR A PAIN PROCEDURE. WHILE PT WAS GETTING DRESSED HER DRIVER/ROOMMATE TRIED TO ADJUST THE FOOT REST, METAL SLICED HER LEFT INDEX FINGER APPROX 1 CENTIMETER BELOW THE DISTAL FIRST KNUCKLE. THIS INCLUDED THE NAIL TIP OF THE FINGER. THE FINGER TIP WAS PLACED IN ICE AND THE PT WAS DIRECTED TO GO DIRECTLY TO (B)(6) ER VIA MOTOR VEHICLE. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267005 PREMIER CARE CLINER CLINICAL CHAIR FRJ WINCO MFG, LLC 65603 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization