BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWION

    MDR report key: 8829950 · Received July 26, 2019

    Report

    Report Number
    3004730072-2019-00003
    Event Type
    Injury
    Date Received
    July 26, 2019
    Report Date
    August 2, 2019
    Manufacturer
    ALBER GMBH
    Product Code
    ITI
    PMA / PMN Number
    K151717
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE DEALER. THE END-CUSTOMER USED THE DEVICE ON A CROSS-COUNTRY ENVIRONMENT (GRASS) AND THE WHEELCHAIR TIPPED OVER AND THE HANDRIM BROKE. NO MEDICAL INTERVENTION WAS SOUGHT FOR THE REPORTED INJURY. THE PERMISSIBLE CONDITIONS OF USE (LOCATIONS OF OPERATION) ACCORDING THE INSTRUCTIONS FOR USE HAS NOT BEEN FOLLOWED.

    Description of Event or Problem · 0

    ALBER GMBH RECEIVED AN UPDATE BY THE DEALER. THE END-CUSTOMER USED THE DEVICE ON A CROSS-COUNTRY ENVIRONMENT (GRASS) AND THE WHEELCHAIR TIPPED OVER AND THE HANDRIM BROKE. NO MEDICAL INTERVENTION WAS SOUGHT FOR THE REPORTED INJURY.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURED IN U.S. INVOLVING A PRODUCT MANUFACTURED BY ALBER (B)(4). ALBER (B)(4) IS FILING THIS REPORT BECAUSE THE DEVICE IS MARKETED AND SOLD IN THE U.S. THE END CUSTOMER WROTE THAT THE PUSH-RIM OF ONE TWION WHEEL BROKE AT THE ATTACHMENT POINT AND SHE CUT HER HAND AND FELL OUT OF THE WHEELCHAIR. SEVERAL CONTACT ATTEMPTS TO THE END CUSTOMER AS WELL DEALER WERE CARRIED OUT TO FIND OUT WHETHER A MEDICAL INTERVENTION WAS SOUGHT FOR THE REPORTED INJURY, BUT AS OF THE DATE OF THIS REPORT NO FEEDBACK OR FURTHER INFORMATION ABOUT THE INJURY OR MEDICAL INTERVENTION RECEIVED. THE RESPONSIBLE DEALER PLACED A REPLACEMENT ORDER FOR THE TWION WHEEL. ALBER (B)(4) WILL EVALUATE THE TWION WHEEL ONCE RETURNED. THE DATE OF THE EVENT IS NOT KNOWN. IF MORE INFORMATION IS RECEIVED, A FOLLOW-UP RECORD WILL BE FILED.

    Description of Event or Problem · 1

    ALBER (B)(4) RECEIVED A CHAT BY END CUSTOMER ON (B)(6) 2019. SHE RELATES THAT ONE PUSH-RIM OF THE TWION WHEEL BROKE AT THE ATTACHMENT POINT AND SHE CUT HER HAND AND FELL OUT OF THE WHEELCHAIR. SEVERAL CONTACT ATTEMPTS TO THE END CUSTOMER AS WELL DEALER WERE CARRIED OUT TO FIND OUT WHETHER A MEDICAL INTERVENTION WAS SOUGHT FOR THE REPORTED INJURY, BUT UNTIL TODAY NO FEEDBACK OR FURTHER INFORMATION ABOUT THE INJURY OR MEDICAL INTERVENTION RECEIVED. AS PRECAUTION WE REPORT THIS EVENT TO THE AUTHORITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623537 TWION POWER ADD ON DRIVE ITI ALBER GMBH EU:1566460

    Patients

    Seq Age Sex Outcome Treatment
    1 Other