BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGIC MOBILITY

    MDR report key: 18226686 · Received November 29, 2023

    Report

    Report Number
    3019677893-2023-00003
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    July 9, 2023
    Report Date
    January 31, 2025
    Manufacturer
    SUNRISE MEDICAL LLC
    Product Code
    ITI
    PMA / PMN Number
    K211574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BACKGROUND: MAGIC MOBILITY POWER WHEELCHAIR OWNER'S MANUAL, PAGE 14 STATES: "TRAPPING HAZARDS! YOUR POWERCHAIR HAS NUMEROUS AREAS WHICH MAY BE TRAPPING/PINCHING HAZARDS. ALWAYS EXERCISE CAUTION WHEN USING YOUR POWER FUNCTIONS AND ENSURE THAT BODY PARTS, CLOTHING OR OBJECTS ARE CLEAR OF THE MECHANISMS DURING OPERATION. SERIOUS PERSONAL INJURY CAN OCCUR." DISCUSSION: IN REVIEWING THE COMPLAINT, THE END USER REPORTS THAT WHILE DRIVING HIS WHEELCHAIR, HE STEERED LEFT, AND HIS RIGHT FOOT FELL FROM THE FOOTPLATE. WHEN THIS HAPPENED, THE END USER'S FOOT LANDED BETWEEN THE FOOTPLATE AND THE WHEEL, CAUSING THE WHEEL TO ALLEGEDLY "DRIVE UP" THE END USER'S LEG. THE END USER STATES THAT HIS FOOT FELL FROM THE FOOTPLATE BECAUSE THE WHEELCHAIR DID NOT COME WITH "HEEL STRAPS." THE WHEELCHAIR THAT THE INCIDENT OCCURRED ON WAS BUILT TO THE SPECIFICATIONS OF THE END USER'S PREVIOUS WHEELCHAIR. THERE IS NO EVIDENCE OF MALFUNCTION FROM THE WHEELCHAIR. UPON RECEIVING PHOTOS FROM THE END USER, THERE IS AN INDICATION THAT THE WHEELCHAIR WASN'T WELL MAINTAINED. THE POSTERIOR SECTIONS OF THE FOOTPLATE HAVE SIGNIFICANT WEAR AND WOULD LIKELY NOT PROVIDE PROPER SUPPORT TO THE END USER'S FOOT, WHICH COULD POTENTIALLY LEAD TO THE FOOT FALLING OFF THE FOOTPLATE. THE END USER VISITED THE EMERGENCY ROOM WHERE IT WAS DETERMINED THAT HE BROKE HIS RIGHT TIBIA. THE END USER WAS INSTRUCTED TO WEAR A WALKING BOOT WHILE HE HEALED AND DUE TO HEEL SORES BEGINNING TO FORM; HOWEVER, HE ENDED UP USING AN ANKLE-FOOT ORTHOTIC FOR TREATMENT. THE END USER REPORTS THAT THE BONE HAS HEALED AND DOES NOT REQUIRE SURGERY. CONCLUSION: IN CONCLUSION, THERE IS NO EVIDENCE OF MALFUNCTION FROM THE WHEELCHAIR. THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DUE TO THE ALLEGATION OF A SERIOUS INJURY THAT REQUIRED MEDICAL INTERVENTION (BROKEN TIBIA), THIS MDR IS BEING FILED. ADDITIONAL NOTE: THE ORIGINAL MDR WAS SUBMITTED ON 11/16/2023 WITHIN THE 30-DAY REQUIREMENT DEFINED IN 21 CFR 803 WITH A SUCCESSFUL ACKNOWLEDGEMENT 1 AND 2, HOWEVER IT WAS IDENTIFIED THAT ACKNOWLEDGEMENT 3 INDICATED THAT THE SUBMISSION FAILED AND WAS NOT ENTERED IN THE CDRH DATABASE. IT WAS FOUND THAT THE CAUSE OF THIS FAILURE WAS ATTRIBUTED TO AN ERROR IN THE MANUFACTURER NUMBER AND A LACK OF CLEAR GUIDANCE FOR VERIFYING SUCCESSFUL SUBMISSION IN THE ORGANIZATION'S PROCEDURES. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED CORRECTING THE MANUFACTURER NUMBER IN THE ORGANIZATION'S PROCEDURES AND DEFINING THE STEPS REQUIRED TO VERIFY SUCCESSFUL ENTRY INTO THE CDRH DATABASE. WHILE THE ORIGINAL SUBMISSION WAS ON-TIME, THIS FILING IS BEING MADE BECAUSE THE ORIGINAL SUBMISSION WAS NOT SUCCESSFULLY ENTERED INTO THE CDRH DATABASE WITHIN THE 30-DAY SUBMISSION REQUIREMENT.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. THIS MDR ONLY CONTAINED THE DI PORTION OF THE UDI INCLUDED IN THE MEDWATCH FORM. THE MDR HAS BEEN CORRECTED BY ADDING THE FULL UDI NUMBER.

    Description of Event or Problem · 0

    THE END USER REPORTS THAT WHILE DRIVING HIS WHEELCHAIR, HIS RIGHT FOOT FELL FROM THE FOOT PLATE, IN BETWEEN THE FOOTPLATE AND THE WHEEL, LEADING THE WHEELCHAIR TO "DRIVE UP" HIS LEG. THE WHEELCHAIR THAT THE INCIDENT OCCURRED ON WAS BUILT TO THE SPECIFICATIONS OF THE END USER'S PREVIOUS WHEELCHAIR. THERE IS NO EVIDENCE OF MALFUNCTION FROM THE WHEELCHAIR. THE END USER BROKE HIS RIGHT TIBIA DURING THE INCIDENT. THE END USER REPORTS THAT THE BONE HAS HEALED AND DOES NOT REQUIRE SURGERY.

    Description of Event or Problem · 0

    THIS REPORT REPRESENTS A CORRECTION TO A PREVIOUSLY SUBMITTED MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79319 MAGIC MOBILITY POWERED WHEELCHAIR ITI SUNRISE MEDICAL LLC XTREME 8

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Hospitalization| O