BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGIANCE HEALTHCARE CORP.

    MDR report key: 103117 · Received July 1, 1997

    Report

    Report Number
    103117
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    April 24, 1997
    Report Date
    June 1, 1997
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD DAVOL JACKSON - PRATT DRAIN INSERTED 4/19/97. ON 4/24/97 UPON REMOVAL OF PT'S DRESSING THE JACKSON PRATT DRAIN WAS SEEN TO BE BROKEN ABOUT 1/2 INCH FROM THE PLACE WHERE THE CLEAR TUBING MEETS THE DRAIN. PT REQUIRED AN ADD'L SURGICAL PROCEDURE TO REMOVE THIS DRAIN (RETURNED SECTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE HEALTHCARE CORP. Implant SURGICAL DRAIN GCY ALLEGIANCE HEALTHCARE CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R