BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURG PATXRAY 1/4X1/4-200

    MDR report key: 16946524 · Received May 17, 2023

    Report

    Report Number
    3014334038-2023-00068
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    April 28, 2023
    Report Date
    June 3, 2023
    Manufacturer
    RAYNHAM
    Product Code
    HBA
    UDI-DI
    20886704036477
    PMA / PMN Number
    K880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGICAL PATTY (828810PL) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, THE REPORTER STATED THAT THE SURGEON PULLED ON THE STRING WHEN REMOVING THE PATTIES, WHICH IS AGAINST THE INTENDED USE AS LAID OUT IN THE IFU. THE IFU FOR THE PRODUCT EXPLICITLY STATES TO NOT REMOVE PATTIES BY PULLING ON THE STRING. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT IS IMPROPER USE OF PRODUCT (REMOVING PATTIES BY PULLING ON THE STRING). IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A FACILITY REPORTED A SURGICAL PATTY (ID 801399) WAS PLACED IN SITU ON THE BRAIN. HOWEVER, WHEN SURGEON WENT TO REMOVE PATTY BY PULLING THE STRING, THE STRING CAME AWAY AND LEFT THE PATTY IN SITU. THE PATTY WAS REMOVED FROM BRAIN AFTER IT WAS NOTICED TO BE STILL IN SITU AFTER PULLING THE STRING OFF. WHEN THE PATTY WAS PLACED ON THE BRAIN IT WAS NOT MOISTENED AS IT WAS ALREADY IN SITU TO ABSORB BLOOD. THE PATTIES WERE MOISTENED WITH RINGERS SOLUTION WITHIN 5 MINUTES PRIOR TO USE. IT WAS NOT ALTERED OR CUT FROM THE ORIGINAL SIZE PRIOR TO USE, AND NO DELAY OF THE PROCEDURE WAS REPORTED. SURGICAL PROCEDURE: RETRO SIGMOID REPAIR OF RIGHT MASTOID ENCEPHALOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500711 SURG PATXRAY 1/4X1/4-200 SURGICAL PATTIES HBA RAYNHAM 80-1399 HR2768 20886704036477

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male