BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8163718 · Received December 14, 2018

    Report

    Report Number
    8163718
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    November 14, 2018
    Report Date
    November 29, 2018
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HOLE IN BASIN WRAP WITHIN STERILE SUPPLY PACK. APPEARS TO BE SUPPLY CONFIGURATION WITHIN PACK. NO COMPROMISE IN EXTERIOR PACK STERILITY; COMPROMISE ONLY IF SPLASH WRAP, SPLASH BASIN, AND CONTENTS WERE TO BE INSERTED INTO RING STAND. NO PATIENT EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003616 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC. CDLP15C 750181

    Patients

    Seq Age Sex Outcome Treatment
    1