BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD DAVOL

    MDR report key: 166653 · Received May 8, 1998

    Report

    Report Number
    166653
    Event Type
    Injury
    Date Received
    May 8, 1998
    Date of Event
    April 2, 1998
    Report Date
    April 10, 1998
    Manufacturer
    C.R. BARD MEDICAL, INC.
    Product Code
    GCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING REMOVAL OF SILICONE ROUND DRAIN, DRAIN TUBING BROKE LEAVING AN 8 CM. PIECE OF TUBING INSIDE THE RIGHT HIP SOFT TISSUE. RETURN TO SURGERY 4/10/1998 FOR REMOVAL; BROKEN PIECE LOOSE IN WOUND, NOT BOUND UP BY SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD DAVOL Implant SILICONE ROUND DRAIN TUBE GCY C.R. BARD MEDICAL, INC. 0070320 *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R