BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL PATTIE, 1/2 X 1/2

    MDR report key: 5286410 · Received December 10, 2015

    Report

    Report Number
    1226348-2015-10744
    Event Type
    Injury
    Date Received
    December 10, 2015
    Date of Event
    November 18, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBN
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT WE RECEIVED 6 EMPTY PACKAGES (OPEN PACKAGED WITH NO PRODUCT INSIDE). AN E-MAIL EXPLAINS: I WAS PROCESSING THE RETURN THE SAMPLE, HOWEVER I DETECTED THAT THERE AREN´T SAMPLE; ONLY EMPTY PACKAGING. I CONTACTED TO SALES REPRESENTATIVE AND HE TOLD ME THAT SAMPLE WAS SCRAPPED IN THE HOSPITAL BECAUSE OF HOSPITAL´S POLITICS ALL CONTAMINATED SAMPLE ARE SCRAPPED IN THE HOSPITAL. WITHOUT THE PRODUCT IT IS NOT POSSIBLE TO PERFORM AN EVALUATION AND DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. THERE HAVE NOT BEEN ANY COMPLAINTS OF THIS TYPE FOR THIS PRODUCT CODE AND LOT NUMBERS 512240 (4) AND 506914 (2). BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE DISCARDED.

    Additional Manufacturer Narrative · 1

    GTIN: NOT AVAILABLE. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PLEASE SEE BELOW THE DISTRIBUTOR'S ANSWERS, ABOUT THIS COMPLAINT: ARE YOU SAYING IN THE COMPLAINT THAT THE RADIOPAQUE MARKERS DID NOT SHOW UP IN THE X-RAY. IT WAS UNCLEAR TO ME WHAT THE REPORTED PROBLEM WAS. ALSO, THE COMPLAINT LISTS TWO ITEMS: THE FIRST, PART NUMBER 801400, INVOLVES 2 ITEMS. THE SECOND PART NUMBER ON THE COMPLAINT, # 801402, INVOLVES 4 ITEMS. BOTH OF THESE ITEMS ARE PACKAGED IN BOXES OF 20 PACKS, EACH CONTAINING 10 PATTIES. MY QUESTION IS: ARE YOU SAYING THAT THE PROBLEM IS WITH THE PACKS OR THE ENTIRE BOX OF 200 PATTIES: THE LOOK FOR THEM IN A SURGERY AND DID NOT FOUND THE MARKERS, AS A RESULT OF THAT THEY TESTED THE REMAINDER OF THE STOCK AND WHERE NOS ABLE TO FOUND THE MARKERS, THEN THEY CALL US TO REPLACE THE ALL OF THEIR STOCK , WHICH WE DID. AS THEY SEE IT IS A PROBLEM WITH ALL THEIR STOCK THE ENTIRE BOX, AND EVERY PART NUMBER. ALSO, PLEASE HELP US WITH THE FOLLOWING QUESTIONS: WERE BOTH OF THESE PRODUCTS INVOLVED IN THE SAME PROCEDURE: NO THEY TOOK AN IMAGE, IS NOT CLEAR IF IT WAS AN X-RAY OR A FLUOROSCOPY AND DID NOT FOUND THE RADIOPAQUE MARKERS (ONE PRODUCT WAS USED). DID THESE EVENT OCCUR INTRA-OPERATIVELY: YES WITH IN REFERENCE NUMBER. DID THIS EVENT CAUSE ANY DELAY IN SURGERY OVER 30 MINUTES: NO. WERE THERE ANY ADVERSE CONSEQUENCES TO THE PATIENT: NO. WHAT ACTIONS WERE TAKEN AS A RESULT OF THIS INCIDENT: THEY TOOK ALL THE REMAINING STOCK OF PATTIES AND TESTED THEM UNDER X-RAY AND WHERE NOT ABLE TO FIND THE RADIOPAQUE MARKER.

    Description of Event or Problem · 1

    YESTERDAY HAD DRAWBACKS IN SKULL SURGERY TO INSERT A COTONOID IN THE CAVITY AND TAKING A PLAQUE INTENSIFIER CAN NOT SHOW WHITE MATERIAL, THING THAT IS NOT RIGHT BECAUSE IT COMES COMPOUND WITH RADIOPAQUE MATERIAL TO BE SHOWING THROUGH RX FOR PATIENT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816533 SURGICAL PATTIE, 1/2 X 1/2 SURGICAL SPONGE HBN CODMAN & SHURTLEFF, INC. 506914

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention