BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPONGE,LAP,18"X18",DLX,XR,ST

    MDR report key: 13001432 · Received December 14, 2021

    Report

    Report Number
    1417592-2021-00218
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 11, 2021
    Report Date
    December 14, 2021
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    GDY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THERE WERE "BITS OF GAUZE" INSIDE OF THE PATIENT AND THEY DIDN'T KNOW WHERE IT WAS COMING FROM. THE FACILITY REPORTED THAT WHEN THEY INVESTIGATED, THEY FOUND THAT A LAP SPONGE SEPARATED AT THE SEAMS AND THE CONTENTS WERE BEING DISPERSED INSIDE OF THE PATIENT. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. NO ADDITIONAL INFORMATION IS AVAILABLE. A SAMPLE WAS NOT RETURNED FOR EVALUATION. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LAP SPONGE SEPARATED AT THE SEAMS AND CONTENTS WERE DISPERSED INSIDE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899162 SPONGE,LAP,18"X18",DLX,XR,ST GDY MEDLINE INDUSTRIES, LP 84320110111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other