BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAUZE,SPONGE,4"X4",8PLY,NS,LF,4000/CS

    MDR report key: 10901279 · Received November 25, 2020

    Report

    Report Number
    1417592-2020-00141
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    November 6, 2020
    Report Date
    November 24, 2020
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    NAB
    UDI-DI
    10080196694013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED FRAGMENTS OF NONSTERILE 100% COTTON WOVEN GAUZE SPONGE HAD COME OFF ON TO A PATIENT'S SURGICAL SITE DURING A MOHS PROCEDURE. EMAIL RECEIVED BY FACILITY REPRESENTATIVE, WITH ADDITIONAL INFORMATION RELATED TO THIS INCIDENT. THE REPORTER STATES ON (B)(6) 2020 FRAGMENTS OF NONSTERILE 100% COTTON WOVEN GAUZE SPONGE HAD COME OFF ON TO A PATIENT'S SURGICAL SITE AT THE END OF A MOHS PROCEDURE. REPORTER STATES, THE FRAGMENTS WERE REMOVED WITH INSTRUMENTS AND IRRIGATION. NO SERIOUS INJURY WAS REPORTED. REPORTER STATES NO SAMPLES ARE AVAILABLE FOR RETURN AND EVALUATION. DUE TO THE REPORTED INCIDENT, MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED FRAGMENTS OF NONSTERILE 100% COTTON WOVEN GAUZE SPONGE HAD COME OFF ON TO A PATIENT'S SURGICAL SITE DURING A MOHS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364381 GAUZE,SPONGE,4"X4",8PLY,NS,LF,4000/CS NAB MEDLINE INDUSTRIES INC. 6052006036 10080196694013

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention