BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELICOT

    MDR report key: 3576730 · Received December 30, 2013

    Report

    Report Number
    1221144-2013-00001
    Event Type
    Injury
    Date Received
    December 30, 2013
    Date of Event
    October 30, 2013
    Report Date
    November 18, 2013
    Manufacturer
    AMERICAN SURGICAL COMPANY
    Product Code
    HBA
    PMA / PMN Number
    K121822
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECTED DEVICE WAS NOT RETURNED TO THE MFR FOR EVALUATION. AFTER 4 ATTEMPTS, ON DIFFERENT DAYS VIA PHONE, AMERICAN SURGICAL COMPANY RECEIVED A CALL BACK FROM THE INITIAL REPORT WHO, AFTER A SUBSEQUENT PHONE CALL INDICATED THAT THE HOSPITAL'S LEGAL PEOPLE ADVISED THE INITIAL REPORTER NOT TO RETURN THE DEVICE TO THE MFR. EVEN THOUGH THE DEVICE WAS NOT RETURNED, AMERICAN SURGICAL TOOK THE FOLLOWING ACTIONS: SEVERAL DELICOT 63-01 POUCHES CONTAINING (B)(4) DEVICES EACH WHERE VISUALLY INSPECTED. THIS CONFIRMED THE PRESENCE OF THE RADIOPAQUE ON ALL OF THE DEVICES. FOUR DELICOT 63-01 DEVICES WHERE RANDOMLY SELECTED FROM THE RETAINS AND TAKEN TO A LAB FOR X-RAY TESTING. ALL (B)(4) DEVICES WERE CLEARLY DETECTED.

    Description of Event or Problem · 1

    PER VOLUNTARY MEDWATCH REPORT FROM HOSPITAL: "THE RADIO-OPAQUE MARKER STRIP ON THE DELICOT 5 MM X 5 MM SPONGE WAS NOT SEEN ON X-RAY." "WHEN THE YELLOW TAIL COTTON PATTIES WERE REMOVED AND COUNTED DURING NEUROSURGERY, ONE OF THE SMALL COTTON PATTIES WAS NOT ATTACHED TO ITS YELLOW TAIL. INTRA-OPERATIVE X-RAY AND INTRA-OPERATIVE MRI WERE NEGATIVE FOR FOREIGN BODY IN THE CAVITY. THE FOLLOWING DAY AN AREA HIGHLY SUSPICIOUS FOR FOREIGN MATERIAL WAS SEEN ON THE ROUTINE POST-OP CT. THE PATIENT RETURNED TO SURGERY FOR EXPLORATION AND THE COTTON PATTIE WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680201 DELICOT COTTONOID OR COTTON PATTIE HBA AMERICAN SURGICAL COMPANY 63-01

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R