BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGINEEDLE

    MDR report key: 20472 · Received January 31, 1995

    Report

    Report Number
    20472
    Event Type
    Injury
    Date Received
    January 31, 1995
    Date of Event
    November 23, 1994
    Report Date
    January 30, 1995
    Manufacturer
    U.S. SURGICAL CORP.
    Product Code
    FHP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 11/23/94, ONE OF OUR PTS UNDERWENT A LAPAROSCOPIC SURGICAL PROCEDURE. THE PT WAS RELEASED FROM FACILITY WITHOUT APPARENT INCIDENT. ON 1/11/95, CONTINUOUS QUALITY IMPROVEMENT COMMITTEE RECEIVED A REPORT FROM THE SURGEON RELATING THE FOLLOWING EVENT. ON 12/10/94, THE PT HAD TO HAVE THE OUTER SHEATH OF A NEEDLE REMOVED FROM THE BUTTOCK AREA. THE SHEATH HAD APPARENTLY BECOME DETACHED, AND HAD WORKED ITS WAY FROM THE PT'S ABDOMEN, TO THE BUTTOCK AREA. NEEDLE WAS APPARENTLY RECEIVED DEFECTIVE FROM THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGINEEDLE PNEUMOPERITONEUM NEEDLE FHP U.S. SURGICAL CORP. 172016 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R