BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M BRAND AGEE CARPAL TUNNEL RELEASE SYSTEM

    MDR report key: 205425 · Received January 7, 1999

    Report

    Report Number
    2110898-1999-00001
    Event Type
    Injury
    Date Received
    January 7, 1999
    Manufacturer
    3M CO.
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED TO MFR: CUSTOMER REPORTED DURING ELEVATION OF THE BLADE A SMALL PART (SPRING) OF THE BLADE ASSEMBLY BECAME LOOSE. THE SURGEON HAD TO WITHDRAW THE BLADE IN THE UPRIGHT POSITION. THE METAL PART HAD TO REMAIN IN THE CARPAL TUNNEL. THE SURGEON DECIDED TO SWITCH TO AN OPEN PROCEDURE TO REMOVE THE METAL PART. THE PT IS WELL AND THE RESULT OF THE PROCEDURE IS IN LINE WITH THE EXPECTED. NO INJURY OR UNEXPECTED RISK WITH SERIOUS CONSEQUENCES FOR THE PT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M BRAND AGEE CARPAL TUNNEL RELEASE SYSTEM CARPAL TUNNEL RELEASE SYSTEM HRX 3M CO. NA FEB98-267

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention