BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRSG,NON-ADH,DRY, 8X3'',PEEL PCK

    MDR report key: 10086818 · Received May 26, 2020

    Report

    Report Number
    1018120-2020-00412
    Event Type
    Injury
    Date Received
    May 26, 2020
    Date of Event
    March 17, 2020
    Report Date
    May 26, 2020
    Manufacturer
    COVIDIEN
    Product Code
    NAD
    UDI-DI
    10884521065307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN DISCARDED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.  AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.  IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT HAD CRANIOTOMY SURGERY AND A RETAINED SPONGE WAS NOTED IN THE MRI POST SURGERY. DISCLOSURE TO THE PATIENT/ PARENTS WAS DONE. PER NEUROSURGERY PROGRESS NOTES, IN REVIEWING THE PATIENT¿S POSTOP MRI, THERE WAS A NOTABLE T2 HYPERINTENSITY IN THE INTERHEMISPHERIC FISSURE POSTERIORLY WHICH WAS NOT NOTED ON THE PATIENT¿S PREOPERATIVE MRI. THERE WAS A CONCERN FOR RETAINED FOREIGN OBJECT, SPECIFICALLY TELFA USED FOR PROTECTION OF THE CEREBRAL CORTEX DURING THE DISSECTION OF THE INTERHEMISPHERIC FISSURE. ALTHOUGH THE SURGICAL COUNTS WERE CORRECT AT THE END OF THE OPERATIVE PROCEDURE, THE TELFA WAS CUT INTO STRIPS AND THEN COUNTED. THE TELFA USED DOES NOT HAVE STRINGS ATTACHED TO FACILITATE COUNTING. IN REVIEWING WITH OTHER OPERATIVE PERSONNEL PRESENT DURING THE SURGERY, IT APPEARS THAT ONE PIECE OF COUNTED TELFA MAY HAVE BEEN CUT AGAIN AND THE COUNT NOT UPDATED. THIS MAY ACCOUNT FOR THE DISCREPANCY BETWEEN THE CORRECT SURGICAL COUNT AND THE APPARENT RETAINED TELFA VISUALIZED ON MRI. THE PATIENT WAS SCHEDULED TO GO BACK TO THE OPERATING ROOM FOR THE REMOVAL OF THE RETAINED TELFA (EXPLORATION OF LEFT FRONTAL CRANIOTOMY FOR REMOVAL OF RETAINED FOREIGN BODY). THE FOREIGN OBJECT WAS SUCCESSFULLY REMOVED. THE CURRENT STATUS OF THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550478 DRSG,NON-ADH,DRY, 8X3'',PEEL PCK DRESSING,WOUND,OCCLUSIVE NAD COVIDIEN 1238 19M026062 10884521065307

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other