BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY LOW BLUE 520 9153642240

    MDR report key: 8452036 · Received March 26, 2019

    Report

    Report Number
    9615290-2019-00001
    Event Type
    Injury
    Date Received
    March 26, 2019
    Report Date
    February 27, 2019
    Manufacturer
    INVACARE SWEDEN, REA (DOLOMITE)
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEGACY ROLLATOR WAS INSPECTED BY INVACARE CORPORATION AND THE VISUAL OBSERVATION INDICATED THAT THE RIGHT REAR LEG TUBING WAS BENT INWARD, SUCH THAT THE WHEEL ANGLED IN NOTICEABLY. THE RIGHT REAR WHEEL ASSEMBLY APPEARED UNDAMAGED AND THERE WERE NO ABRASIONS OR SIGNS OF IMPACT VISIBLE ON THE OUTER SURFACE OF THE BENT LEG TUBE. ASIDE FROM THE BENT RIGHT REAR LEG TUBE, THE ROLLATOR WAS STURDY AND IN GOOD CONDITION. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE DAMAGED CONDITION THE ROLLATOR WAS RECEIVED IN. IN CONCLUSION, THE FAILURE OBSERVED IS CONSISTENT WITH THE COMPLAINANT'S ALLEGATION THAT THE END USER TURNED WHILE WALKING WITH THE DEVICE. ADDITIONAL STRESS ON THE RIGHT REAR LEG TUBE RESULTING FROM THE TORQUE OF THE TURNING ACTION MOST LIKELY CAUSED THE FRAME FAILURE.

    Description of Event or Problem · 0

    THE END USER WAS WALKING INTO THE LIVING ROOM AREA OF HIS APARTMENT. HE STOPPED AND TURNED HIS HEAD AND UPPER BODY SLIGHTLY TO ANSWER HIS WIFE WHO HAD SPOKEN TO HIM. THE RIGHT SIDE OF THE WALKER COLLAPSED CAUSING HIM TO FALL TO THE FLOOR. THE END USER WAS TAKEN TO THE HOSPITAL EMERGENCY ROOM AND DIAGNOSED WITH A PARTIAL L. BICEP TEAR. THE FAMILY RELATED THE INJURY IS BEING TREATED CONSERVATIVELY AND NOT TO BE SURGICALLY REPAIRED DUE TO THE END USERS PRE-EXISTING MEDICAL CONDITIONS.

    Additional Manufacturer Narrative · 1

    THE DOLOMITE LEGACY LOW ROLLATOR WAS RETURNED TO THE DEALER. THE DEALER RETURNED THE ROLLATOR TO INVACARE (B)(4) WHO IS SHIPPING IT TO INVACARE CORPORATION IN THE UNITED STATES FOR EVALUATION. THE RECORD WILL BE UPDATED WHEN MORE INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE END USER WAS WALKING INTO THE LIVING ROOM AREA OF HIS APARTMENT. HE STOPPED AND TURNED HIS HEAD AND UPPER BODY SLIGHTLY TO ANSWER HIS WIFE WHO HAD SPOKEN TO HIM. THE RIGHT SIDE OF THE WALKER COLLAPSED CAUSING HIM TO FALL TO THE FLOOR. THE END USER WAS TAKEN TO THE HOSPITAL EMERGENCY ROOM AND DIAGNOSED WITH A PARTIAL L. BICEP TEAR. THE FAMILY RELATED THE INJURY IS BEING TREATED CONSERVATIVELY AND NOT TO BE SURGICALLY REPAIRED DUE TO THE END USERS PRE-EXISTING MEDICAL CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246075 LEGACY LOW BLUE 520 9153642240 WALKER/ROLLATOR ITJ INVACARE SWEDEN, REA (DOLOMITE) NA:12052-37-86

    Patients

    Seq Age Sex Outcome Treatment
    1 Other