BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M300

    MDR report key: 8544206 · Received April 24, 2019

    Report

    Report Number
    1221084-2019-00015
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    December 23, 2018
    Report Date
    April 24, 2019
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL RECEIVED CORRESPONDENCE ON (B)(6) 2019 FROM A LAW FIRM IDENTIFYING THEMSELVES AS REPRESENTING THE END-USER REGARDING AN UNDISCLOSED FAILURE HAVING OCCURRED WITH THE DEVICE CAUSING AN UNDISCLOSED INJURY TO THE END-USER. ON (B)(6) 2019, PERMOBIL COUNSEL WAS ABLE TO OBTAIN VERBAL REPORTS FROM OPPOSING COUNSEL ALLEGING AS THE END-USER WAS SEATED IN THEIR DEVICE, THE ARMREST ASSEMBLY BECAME DETACHED WHICH CAUSED THE END-USER TO LOSE POSITIONING AND FALL FROM THE SEATING. THIS VERBAL REPORT ALLEGED THE END-USER SUFFERED UNSPECIFIED INJURIES TO THEIR SPINE AND INJURIES REQUIRING UNSPECIFIC DENTAL WORK. REPORTS GIVEN TO PERMOBIL INDICATE THE DEVICE HAD BEEN REPAIRED AND END-USER IS CURRENTLY USING THE DEVICE WITHOUT ANY FURTHER ISSUES BEING NOTED. IT REMAINS UNCLEAR AS TO NATURE OF THE ALLEGED FAILURE AS REPORTING PARTY HAS NOT BEEN FORTHCOMING. PERMOBIL IS UNABLE TO CONFIRM A SPECIFIC COMPONENT MALFUNCTION AS THE COMPONENTS ALLEGED TO HAVE FAILED WERE NOT RETURNED TO PERMOBIL AND THEIR WHEREABOUTS ARE UNKNOWN. PERMOBIL WILL CONTINUE TO INVESTIGATE AND IF FURTHER INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED AND THE DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT ALLEGING AS END-USER WAS SEATED IN THEIR DEVICE, THE ARMREST DETACHED ALLOWING THE END-USER TO LOSE POSITIONING AND FALL OUT OF THE SEATING. REPORTS CLAIM THE END-USER SUFFERED AN UNSPECIFIED SPINAL INJURY AND INJURIES REQUIRING DENTAL PROCEDURES TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338014 PERMOBIL M300 POWER WHEELCHAIR ITI PERMOBIL INC. M300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other