BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 11822539 · Received May 13, 2021

    Report

    Report Number
    1423395-2021-00025
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 13, 2021
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    LRO
    UDI-DI
    10193489487619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED, "TWO SEPARATE INCIDENTS IN WHICH, DR. (B)(6) HAD 2 CASES (ONE THIS WEEKEND/ONE THIS AM) WHERE HE HAD TO PICK-OUT FRAGMENTS OF GAUZE FROM THE ABDOMEN." BOTH INCIDENTS REPORTED TO MEDLINE INDUSTRIES, INC., (B)(6) 2021. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. SAMPLES HAVE NOT BEEN RETURNED FOR EVALUATION. INVESTIGATION SUMMARY: "THE ACCOUNT REPORTED FINDING GAUZE WAS FRAYING/FLAKING DURING USE. THE REPORTED ISSUE OCCURRED IN ITEM DYNJV0264I (LOT 21BMB758). BASED ON THE INFORMATION PROVIDED, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE WITHOUT A PHOTO OR SAMPLE." DUE TO THE REPORTED INCIDENT, MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MED WATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MED WATCH WILL BE SUBMITTED. INVESTIGATION SUMMARY: "THE ACCOUNT REPORTED FINDING GAUZE WAS FRAYING/FLAKING DURING USE. THE REPORTED ISSUE OCCURRED IN ITEM DYNJV0264I (LOT 21BMB758). BASED ON THE INFORMATION PROVIDED, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE WITHOUT A PHOTO OR SAMPLE." ACTIONS TAKEN AND RECOMMENDATIONS: THIS COMPLAINT HAS BEEN PROVIDED TO THE VENDOR FOR FURTHER EVALUATION. OUR SUPPLIER QUALITY TEAM WILL ALSO MONITOR THIS ISSUE FOR TRENDING PURPOSES. "

    Description of Event or Problem · 1

    IT WAS REPORTED, "TWO SEPARATE INCIDENTS IN WHICH, DR. (B)(6) HAD 2 CASES (ONE THIS WEEKEND/ONE THIS AM) WHERE HE HAD TO PICK-OUT FRAGMENTS OF GAUZE FROM THE ABDOMEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719946 MEDLINE INDUSTRIES, INC. DBD-MAJOR GENERAL PROCEDURE PK-LF LRO MEDLINE INDUSTRIES INC. DYNJV0264I 21BMB758 10193489487619

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention