BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD ALLEN SURGICAL NEEDLE

    MDR report key: 3012574 · Received February 21, 2013

    Report

    Report Number
    1836161-2013-00039
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 13, 2011
    Report Date
    February 21, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: REVIEW OF THE MANUFACTURING PROCESS AS WELL AS HARDNESS AND STRENGTH TESTING WAS PERFORMED ON THE RETURNED SAMPLES.

    Description of Event or Problem · 1

    GETTING READY TO INSERT NEEDLE INTO THE SKIN AND IT BROKE OFF RIGHT BY THE EYE OF THE NEEDLE. BOTH PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77397 RICHARD ALLEN SURGICAL NEEDLE EYED SURGICAL NEEDLE GAB ASPEN SURGICAL PRODUCTS, INC. 2015-06-03

    Patients

    Seq Age Sex Outcome Treatment
    1