BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL C400 CORPUS 3G

    MDR report key: 3230029 · Received July 11, 2013

    Report

    Report Number
    1221084-2013-00013
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 19, 2013
    Report Date
    July 10, 2013
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K041219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER INSPECTED THE WHEELCHAIR AND FOUND THAT IT WAS OPERATING AS INTENDED. THE USER WAS GOING FORWARD DOWN A RAMP AND THE CHAIR TIPPED FORWARD. THE USER DID NOT ORDER ANTI-TIPPERS ON THE WHEELCHAIR. MANUFACTURER WILL PROVIDE ANTI-TIPPERS.

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED A REPORT THAT THE POWER WHEELCHAIR USER WAS GOING FORWARD DOWN A RAMP AND THE WHEELCHAIR TIPPED SLIGHTLY FORWARD. USER MADE A REPORT OF AN UNSPECIFIED INJURY. THE CHAIR WAS NOT ORDERED WITH ANTI-TIPPERS. MANUFACTURER INSPECTED THE WHEELCHAIR AND IT WAS OPERATING NORMALLY. MANUFACTURER WILL SUPPLY END USER WITH ANTI-TIPPERS FOR THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320830 PERMOBIL C400 CORPUS 3G POWER WHEELCHAIR ITI PERMOBIL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other