BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARI-FLEX

    MDR report key: 19400969 · Received May 27, 2024

    Report

    Report Number
    3003764610-2024-00003
    Event Type
    Injury
    Date Received
    May 27, 2024
    Date of Event
    April 4, 2024
    Report Date
    July 16, 2024
    Manufacturer
    OSSUR HF
    Product Code
    ISH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TOP CARBON BLADES SNAPPED AT THE ADAPTER; THE RIGHT BLADE SHOWED NO DELAMINATION, AND THE LEFT BLADE HAD MINOR DELAMINATION. IT IS CONCLUDED THAT THE INJURIES AND PRODUCT FAILURE WERE A RESULT OF THE CRASH. THE FAILURE CLOSELY RESEMBLES THE RESULTS OF THE DROP TESTS INVOLVING SUDDEN IMPACT OF EXTREME FORCE FOCUSED ON THE TOE AREA. THE PRODUCT HAD BEEN IN USE FOR ONLY 11 DAYS BEFORE THE INCIDENT. THE LIKELIHOOD OF THIS TYPE OF FAILURE LEADING TO A HAZARDOUS EVENT RESULTING IN A SERIOUS INJURY IS CONSIDERED REMOTE. FURTHER ACTIONS ARE NOT CONSIDERED WARRANTED.

    Description of Event or Problem · 0

    USER WAS ON A MOTOR CYCLE AND WAS NOT ABLE TO BRAKE. HE FELL AND FRACTURED HIS RIGHT HAND AND GOT A LACERATION ON THE RIGHT KNEE.

    Description of Event or Problem · 0

    USER WAS DRIVING A MOTOR VEHICLE AND WAS NOT ABLE TO BRAKE. HE GOT IN AN ACCIDENT AND FRACTURED HIS RIGHT HAND AND GOT A LACERATION ON THE RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398869 VARI-FLEX PROSTHETIC FOOT ISH OSSUR HF VFPE8280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other