BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN SURGICAL PRODUCTS

    MDR report key: 3008591 · Received March 12, 2008

    Report

    Report Number
    3008591
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 7, 2008
    Manufacturer
    ASPEN SURGICAL PRODUCTS
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EYE OF RICHARD ALLEN NEEDLE BROKE OFF INTO PATIENT WHILE USING #2 ETHIBOND. RETRIEVED AND SECURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPEN SURGICAL PRODUCTS 1/2 TAPES RICHARD ALLEN NEEDLE GAB ASPEN SURGICAL PRODUCTS STYLE# 209503 2010-08 2005-08

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other