BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL PATTIE, 1/2 X 1/2

    MDR report key: 3720439 · Received April 2, 2014

    Report

    Report Number
    1226348-2014-11341
    Event Type
    Injury
    Date Received
    April 2, 2014
    Date of Event
    March 12, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBA
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT, THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. THE FOLLOWING INFORMATION IS INDICATED IN THE INSTRUCTIONS FOR USE WITH THE PRODUCT: "THIS DEVICE IS CONSIDERED RADIOPAQUE IN ACCORDANCE WITH ASTM F640. THE DEVICE MAY NOT BE VISIBLE UNDER ALL RADIOGRAPHIC CONDITIONS. THE SIZE AND POSITION OF THE MARKER MAY IMPACT RADIOPACITY. IN ADDITION, ADJACENT STRUCTURES MAY INHIBIT VISIBILITY. MULTIPLE ANGLES AND MODIFICATION OF RADIOGRAPHY PARAMETERS (E.G. KEVM MAS) MAY BE REQUIRED TO ENHANCE VISIBILITY OF THE MARKER." TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND REPORTED THAT: "DURING A CRANIOTOMY PROCEDURE, ONE PATTIE P/N 80-1400 (1/2" X 1/2") WAS MISSING AND IT COULD NOT BE FOUND UNDER X-RAY. SURGEON DECIDED TO SEARCH FOR THE PATTIE, AND IT WAS FOUND IN THE PATIENT. THEN THE SURGEON DECIDED TO PUT ANOTHER PATTIE, THIS TIME 1/2" X 1 1/2¿ (80-1404), IN THE SAME SURGICAL LOCATION, AND AGAIN IT COULD NOT BE DETECTED UNDER THE X-RAY. THIS IS THE FIRST TIME THAT THIS HAPPENED AT THE HOSPITAL WITH THE CODMAN PATTIES; HOWEVER, THE SURGEON IS CONCERNED ABOUT THE CODMAN PATTIES X-RAY DETECTION. ALL PATTIES WERE DISCARDED AFTER SURGERY; THEREFORE, NO COMPLAINT SAMPLES ARE AVAILABLE FOR EVALUATION. PATTIES LOT NUMBERS ARE ALSO UNKNOWN. SURGERY WAS NOT DELAYED FOR MORE THAN 30 MINUTES, AND NO ADVERSE CONSEQUENCES TO THE PATIENT WERE VERIFIED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197357 SURGICAL PATTIE, 1/2 X 1/2 SURGICAL SPONGE HBA CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention