BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KENEVO

    MDR report key: 8407023 · Received March 11, 2019

    Report

    Report Number
    9615892-2019-00004
    Event Type
    Injury
    Date Received
    March 11, 2019
    Date of Event
    February 18, 2019
    Report Date
    June 3, 2019
    Manufacturer
    OTTO BOCK HEALTHCARE PRODUCTS GMBH
    Product Code
    ISY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION AND INVESTIGATION OF THE DEVICE SHOWED NO RELEVANT ERROR WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE OCCURRED EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION (NOT RETURNED FROM THE CUSTOMER YET); SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 1

    THE KENEVO CAME BACK 01.03 IN OB (B)(4) WITH NO PREVIOUS NOTICE. PATIENT FELL ON (B)(6) GOING DOWN THE STAIRS AT HOME; HE HAD BEEN EQUIPPED FOR 3 WEEKS WITH THE KENEVO (2 WEEKS IN B+ AND ONE IN C). THE KNEE DIDN'T LOCK AND THE PATIENT MENTIONS "IT WAS LIKE PUTTING MY FOOT IN A HOLE". PATIENT WENT TO (B)(6) HOSPITAL FOR XRAYS AND SKIN CARE. BODY DAMAGES : BRACHIAL AND COSTAL HEMATOMAS AND LIGHT WOUNDS ON ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202259 KENEVO EXTERNAL ABOVE KNEE PROSTHESIS ISY OTTO BOCK HEALTHCARE PRODUCTS GMBH 3C60

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization