BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 8163733 · Received December 14, 2018

    Report

    Report Number
    8163733
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    November 14, 2018
    Report Date
    November 28, 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

    STERILE SURGICAL PACK: HAS HOLE IN BACK TABLE COVER THAT IS ALSO USED TO ENCASE THE STERILE SURGICAL SUPPLIES. THE HOLE IS LOCATED IN THE SECTION BENEATH THE FAN FOLD. THE PUNCTURE HOLE IS TUNNELED INSIDE TO OUTSIDE. APPEARS SOME SUPPLY WITHIN PACK IS PENETRATING THE BACK TABLE DRAPE. THIS IS THE 5TH OCCURRENCE REPORTED FOR THIS PARTICULAR PACK WITH THE HOLE IN THE SAME LOCATION. TWO PACKS SUBMITTED WITH THIS REPORT. PREVIOUS 3 PACKS NOT RETAINED. SUSPECT PACKING CONFIGURATION IS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003841 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC. CDBR14D 697181

    Patients

    Seq Age Sex Outcome Treatment
    1