BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELUTIA WOUND DRAIN

    MDR report key: 3881843 · Received May 15, 2014

    Report

    Report Number
    3005168462-2014-00014
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BACTERIN INTERNATIONAL INC.
    Product Code
    OEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG, LOT, CATALOG# 7118, LOT: 028113,016913,028213. ADDITIONAL MANUFACTURE DATE: 01/27/2014 AND 01/28/2014.

    Description of Event or Problem · 1

    INADVERTENT OMISSION OF QUARTERLY (Q4-2013 AND Q1- 2014) DOSE AUDITS/VERIFICATIONS ON LISTED AFFECTED PRODUCTS. ALL OF THE AFFECTED PRODUCTS WERE STERILIZED APPROPRIATELY PER INTERNAL PROCEDURES AT VALIDATED TERMINAL GAMMA IRRADIATION DOSES DESPITE THE OMISSION OF THE DOSE AUDITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289664 ELUTIA WOUND DRAIN DRAINAGE CATHETER OEI BACTERIN INTERNATIONAL INC. 19/24FR WOUND DRAIN 028013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA