BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADKINS STRUTT, 22 CM

    MDR report key: 19969 · Received November 28, 1994

    Report

    Report Number
    19969
    Event Type
    Injury
    Date Received
    November 28, 1994
    Date of Event
    January 27, 1994
    Report Date
    November 18, 1994
    Manufacturer
    PILLING INSTRUMENT CO.
    Product Code
    KTW
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD SURGERY FOR PECTUS BAR PLACEMENT TO TREAT A DEFORMITY OF THE STERNUM ON 6/7/85. AT COMPLETION OF TREATMENT, 7/24/86, THE BAR WAS REMOVED. IN 1993, PT BEGAN DEVELOPING CHEST PAIN WHICH LED TO EMERGENCY SURGERY FOR VIRAL PERICARDITIS ON 5/27/93. A RETAINED PORTION OF BAR WAS EVENTUALLY PICKED UP ON X-RAY. THE RETAINED PORTION WAS SURGICALLY REMOVED 1/27/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADKINS STRUTT, 22 CM Implant PECTUS BAR KTW PILLING INSTRUMENT CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| O