BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEROYAL

    MDR report key: 2759339 · Received September 18, 2012

    Report

    Report Number
    3005225477-2012-00002
    Event Type
    Injury
    Date Received
    September 18, 2012
    Date of Event
    July 25, 2012
    Report Date
    August 1, 2012
    Manufacturer
    GALIA TEXTEL, S.A. DE C.V.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: THE HOSPITAL REPORTED AN X-RAY TOWEL WAS UNDETECTED ON THE X-RAY AND LEFT IN PATIENT. PATIENT RETURNED TO HOSPITAL TEN DAYS AFTER SURGERY WITH INFECTION AT THE INCISION SITE. A CT SCAN WAS TAKEN AND THE TOWEL WAS LOCATED IN ABDOMEN. PATIENT RETURNED TO SURGERY FOR TOWEL TO BE REMOVED. DEROYAL NARRATIVE. THE ROOT CAUSE OF THIS REPORT COULD NOT BE DETERMINED DUE TO NO RETURNED SAMPLE FOR VALIDATION OF DEFECT AND FURTHER INVESTIGATIVE TESTING. REPRESENTATIVE SAMPLES OF THIS RAW MATERIAL WERE PULLED FROM INVENTORY AND X-RAY TESTING PERFORMED. ALL X-RAY ELEMENTS WERE VISIBLE THROUGHOUT THIS INVESTIGATION.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED AN X-RAY TOWEL WAS UNDETECTED ON THE X-RAY AND LEFT IN PATIENT. PATIENT RETURNED TO HOSPITAL TEN DAYS AFTER SURGERY WITH INFECTION AT THE INCISION SITE. A CT SCAN WAS TAKEN AND THE TOWEL WAS LOCATED IN ABDOMEN. PATIENT RETURNED TO SURGERY FOR TOWEL TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL GDY - X-RAY GUAZE/SPONGE GDY GALIA TEXTEL, S.A. DE C.V. 68-408 27917505

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other