BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M300

    MDR report key: 12391526 · Received August 31, 2021

    Report

    Report Number
    1221084-2021-00028
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    July 9, 2019
    Report Date
    August 31, 2021
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL RECEIVED A PETITION AS A DEFENDANT IN A LEGAL CASE WHERE IT WAS ALLEGED THAT THE END-USER SUSTAINED SERIOUS INJURIES BECAUSE OF THE SEATING HAVING BECOME DETACHED ALLOWING IT AND THE END-USER TO FALL FROM THE DEVICE TO THE GROUND. THIS EVENT WAS REPORTED TO HAVE OCCURRED TWO YEARS PRIOR, AND A REVIEW OF CLIENT FILES INDICATE NO REPORT WAS RECEIVED IN/AROUND THE TIMEFRAME THE EVENT WAS REPORTED TO HAVE OCCURRED. CURRENTLY PERMOBIL HAS NOT BEEN ABLE TO INSPECT THE DEVICE, NOR DOES IT HAVE ANY KNOWLEDGE OF THE DEVICE'S STATUS. AT THIS TIME PERMOBIL CANNOT REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE AS A FAILURE MODE HAS YET TO BE ESTABLISHED. PERMOBIL LEGAL COUNSEL WILL BE WORKING WITH OPPOSING COUNSEL TO SCHEDULE AN INSPECTION. UPON RECEIPT OF ANY NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED AND DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    PERMOBIL RECEIVED A CLAIM OF AN EVENT HAVING OCCURRED TWO YEARS PRIOR WHERE IT WAS REPORTED THE SEATING HAVING CATAPULTED THE END-USER FROM THE CHAIR, THROUGH THE AIR, CRASHING TO THE BEDROOM FLOOR. THE REPORT INDICATED THE END-USER SUSTAINED SERIOUS INJURIES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298443 PERMOBIL M300 POWER WHEELCHAIR ITI PERMOBIL INC. M300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization