BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTRA WHEELCHAIR

    MDR report key: 3127033 · Received July 5, 2006

    Report

    Report Number
    2438477-2006-00001
    Event Type
    Injury
    Date Received
    July 5, 2006
    Date of Event
    June 16, 2006
    Report Date
    June 27, 2006
    Manufacturer
    MEDICAL DEPOT, INC (D/B/A DRIVE MEDICAL DESIGN & MFG)
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PLACED IN WHEELCHAIR AND WHEN SEAT WAS COMPLETELY OPENED THE PT'S FINGER WAS CAUGHT BETWEEN SEAT AND CHAIR RESULTING IN A RIGHT LONG FINGER DISTAL PHALANX AMPUTATION SECONDARY TO A SIGNIFICANT BONE CRUSH INJURY. NO OTHER COMPLAINTS REPORTED. NO REPORT OF MALFUNCTION. THIS APPEARS TO BE MISUSE, AS PT PLACED HAND IN MECHANISM BEFORE CHAIR FULLY OPEN. TO THE BEST OF OUR KNOWLEDGE THERE WAS NO MALFUNCTION. DUE TO (B)(4) REGULATIONS WE COULD NOT SPEAK WITH PT OR F/U WITH FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTRA WHEELCHAIR WHEELCHAIR IOR MEDICAL DEPOT, INC (D/B/A DRIVE MEDICAL DESIGN & MFG) STD26DDA UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Disability