BEUDAMED
    FDA Adverse Event Summary report: N

    CASSI BEACON TISSUE MARKER

    MDR report key: 4992066 · Received August 5, 2015

    Report

    Report Number
    3009545273-2015-00001
    Date Received
    August 5, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 20, 2015
    Manufacturer
    SCION MEDICAL TECHNOLOGIES LLC
    Product Code
    NEU
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER IDENTIFIED IN BLOCK IS THE INDIVIDUAL THAT FIRST CONTACTED SCION MEDICAL REPRESENTATIVES ON (B)(6) 2015. NO MDR WAS FILED BY THIS REPORTER. SUBSEQUENTLY, A SECOND FACILITY FILED MDR# (B)(4) ON BEHALF OF THE PT ON (B)(6) 2015 AND UPDATED THE REPORT WITH CORRECTIONS ON (B)(6) 2015.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED IN RESPONSE TO A REPORT SUBMITTED ON (B)(6) 2015, AND RESUBMITTED WITH CORRECTIONS ON (B)(6) 2015 ((B)(4)) BY A HEALTH CARE FACILITY AT THE REQUEST OF THE PT. THE REPORT DESCRIBES AN EVENT ORIGINALLY REPORTED TO SCION MEDICAL TECHNOLOGIES ON (B)(6) 2015 BY THE ATTENDING PHYSICIAN AND DETERMINED AT THAT TIME NOT TO BE REPORTABLE. BASED ON SCION MEDICAL TECHNOLOGIES' DISCUSSION WITH THE ATTENDING PHYSICIAN ON (B)(6) 2015, THE PT HAD THE MARKER IMPLANTED ON (B)(6) 2014 AND FIRST REPORTED SYMPTOMS TO THE ATTENDING PHYSICIAN ON (B)(6) 2015. THE ATTENDING PHYSICIAN EXAMINED THE PT, BUT SAW NO INDICATION OF AN ALLERGIC REACTION OR OTHER REPORTED SYMPTOMS. IN ADDITIONAL, SHE STATED THAT THE PT'S ALLEGED SYMPTOMS ARE NOT CONSISTENT WITH AN ALLERGY FROM A SMALL CLIP. THE DOCTOR REFERED THE PT TO AN ALLERGIST. SHE ALSO IDENTIFIED THAT THIS PT HAS REPORTED OTHER UNSUBSTANTIATED INJURIES. THE DOCTOR REFUSED TO REMOVE THE MARKER AND WAS NOT PLANNING TO TREAT THE PT IN THE FUTURE. SCION STAFF AGREED TO PROVIDE THE PHYSICIAN WITH INFO ABOUT THE BIOCOMPATABILITY OF THE BEACON MARKER MATERIALS. BECAUSE THE ATTENDING PHYSICIAN STATED THAT THE PT SHOWED NO SIGNS OF AN ALLERGIC REACTION OR OTHER ALLEGED SYMPTOMS, AND THE SYMPTOMS ALLEGED BY THE PT WERE NOT CONSISTENT WITH AN ALLERGIC REACTION TO A MARKER, SCION MEDICAL TECHNOLOGIES DETERMINED THAT THE EVENT WAS NOT REPORTABLE. THE PT SUBSEQUENTLY REPORTED TO A SEPARATE HEALTH CARE PROVIDER (BUT PART OF THE SAME PROVIDER SYSTEM) THAT SHE HAD THE MARKER REMOVED AT A DIFFERENT FACILITY IN (B)(6) 2015 AND THAT HER SYMPTOMS SUBSIDED. THIS PROVIDER FILED MDR (B)(4) AT THE REQUEST OF THE PT. THIS PROVIDER PROVIDED A LETTER TO SCION MEDICAL AND UPDATED THEIR REPORT TO CLARIFY THAT THEY FILED THE MDR AT THE PT'S REQUEST AND THE REPORT WAS BASED SOLELY ON WHAT THE PT REPORTED TO HER PHYSICIAN. NEITHER THE ATTENDING PHYSICIAN NOR THE FACILITY FILING THE REPORT CORROBORATED THE ALLEGED SYMPTOMS. THE ATTENDING PHYSICIAN STATED THAT SHE DID NOT SEE EVIDENCE OF THE SYMPTOMS DURING HER EXAMINATION AND THE FACILITY FILING THE REPORT DID NOT EXAMINE THE PT AND FILED THE REPORT SOLELY AT THE PT'S REQUEST. THIS REPORT IS BEING FILED SOLELY TO DOCUMENT THE HISTORY OF THE EVENT REPORTED IN MDR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517604 CASSI BEACON TISSUE MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE NEU SCION MEDICAL TECHNOLOGIES LLC BM1412-50

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR