BEUDAMED
    FDA Adverse Event Summary report: N

    R. WOLFE 101 DRAINAGE CANNULA WITH TROCAR

    MDR report key: 2887509 · Received December 19, 2012

    Report

    Report Number
    2887509
    Date Received
    December 19, 2012
    Date of Event
    November 5, 2012
    Report Date
    December 17, 2012
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A RIGHT KNEE ARTHROSCOPY WAS PERFORMED ON (B)(6) 2012. THE ARTHROSCOPY REVEALED A TEAR OF THE ANTERIOR HORN OF THE MEDIAL MENISCUS AND SIGNIFICANT DEGENERATIVE CHANGES. THE PT HAD A GOOD INITIAL RESPONSE FOR 8 DAYS THEN BEGAN HAVING PAIN. CORTISONE AND SYNVISC INJECTIONS HAD MINIMAL RESPONSE. A REPEAT RIGHT KNEE ARTHROSCOPY WAS COMPLETED ON (B)(6) 2012 FOR FOREIGN BODY REMOVAL, SHAVING OF ARTHRITIC CHANGES, MEDIAL FEMORAL CONDYLE AND PATELLOFEMORAL JOINT. A BROKEN PIECE OF THE VERESS NEEDLE FROM THE ARTHROSCOPY ON (B)(6) 2012 WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R. WOLFE 101 DRAINAGE CANNULA WITH TROCAR DRAINAGE CANNULA WITH TROCAR HRX RICHARD WOLF MEDICAL INSTRUMENTS 101 DRAINAGE CANNULA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R