BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POREX SURGICAL PRODUCTS

    MDR report key: 409659 · Received July 29, 2002

    Report

    Report Number
    409659
    Event Type
    Malfunction
    Date Received
    July 29, 2002
    Date of Event
    July 12, 2002
    Report Date
    July 29, 2002
    Manufacturer
    POREX SURGICAL INC.
    Product Code
    HNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD JONES TUBE INSERTED RIGHT EYE. ATTEMPTED WITH 18MM MEDPORE WRAPPED JONES TUBE; TUBE BROKE AND ALL PIECES RECOVERED. ATTEMPTED 20MM. MEDPORE WRAPPED JONES TUBE; TUBE BROKE ALL PIECES RECOVERED. 3RD ATTEMPT WITH SMALLER, PLAIN JONES TUBE SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POREX SURGICAL PRODUCTS MEDPOR SURGICAL IMPLANT HNL POREX SURGICAL INC. * 003430502 H

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other SUBSEQUENT ATTEMPT WITH 20MM MEDPORE.