BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORD CUTTER

    MDR report key: 1991179 · Received January 28, 2011

    Report

    Report Number
    8043971-2011-00003
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    July 8, 2010
    Report Date
    January 9, 2011
    Manufacturer
    T.A.G. MEDICAL PRODUCTS, CORP. LTD.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED IN ACCORDANCE TO ITS SPECIFICATION AND DEVICE MASTER RECORD. IT IS NOTEWORTHY TO MENTION THAT THE DEVICE WAS USED WELL BEYOND ITS EXPIRATION DATE. THIS DUPLICATED MDR IS BEING SUBMITTED IN ORDER TO COMPLY WITH FDA REQUIREMENTS.

    Description of Event or Problem · 1

    THE DISTRIBUTOR HAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, A PORTION OF THE DISTAL TIP OF A CORD CUTTER BROKE OFF AND FELL INTO THE JOINT SPACE OF THE PT. THE TIP WAS EASILY RETRIEVED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE OR HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORD CUTTER ARTHROSCOPIC INSTRUMENT HRX T.A.G. MEDICAL PRODUCTS, CORP. LTD. 214646 6J2

    Patients

    Seq Age Sex Outcome Treatment
    1