BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II

    MDR report key: 3312656 · Received August 15, 2013

    Report

    Report Number
    3312656
    Event Type
    Malfunction
    Date Received
    August 15, 2013
    Date of Event
    August 2, 2013
    Report Date
    August 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, AS MD WAS CLOSING INCISION, NEEDLE BROKE. (PDSII) XLH Z881. MD FOUND BROKEN PARTS OF NEEDLE. BOTH PARTS OF THE NEEDLE WERE ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394480 PDS II SUTURE, SURGICAL, ABSORBABLE NEW ETHICON, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR