BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THAYES INTELLECTUAL PROPERTY, INC

    MDR report key: 2500950 · Received March 20, 2012

    Report

    Report Number
    MW5024704
    Event Type
    Injury
    Date Received
    March 20, 2012
    Date of Event
    August 31, 2011
    Report Date
    March 12, 2012
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN WAS UTILIZING THE MANOS INCISION LESS CARPEL TUNNEL RELEASE DEVICE DURING A CARPAL TUNNEL PROCEDURE (ON RIGHT SIDE) WHEN THE DEVICE DID NOT DEPLOY ADEQUATELY AND THE PROXIMAL HANDLE SEPARATED ON (B)(6) 2011. THE MANOS SPEAR WAS DEPLOYED DISTALLY THROUGH THE DISTAL PORTAL AND THE DEVICE FAILED AND BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THAYES INTELLECTUAL PROPERTY, INC MANOS INCISION LESS CARPAL TUNNEL DEVICE LXH 523339

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention