BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMEDIOX

    MDR report key: 20500918 · Received October 21, 2024

    Report

    Report Number
    3007895168-2024-00016
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    September 6, 2024
    Report Date
    September 9, 2024
    Manufacturer
    DEMETECH CORPORATION
    Product Code
    NEW
    UDI-DI
    10652927784418
    PMA / PMN Number
    K082097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON SEPTEMBER 6TH, 2024, HCP REPORTED TO THE SALES REPRESENTATIVE THAT A PDO THREAD WAS IMPLANTED ON THE PATIENT'S CHEEK. ACCORDING TO THE HCP, THE PATIENT EXPERIENCED A POP AFTER EATING ON THE LEFT SIDE AND NOW HAS A LITTLE NUMBNESS AND A LITTLE BUMP FORMED IN THE MARIONETTE AREA. HCP ALSO REPORTED THAT THEY TRIED TO REMOVE THE THREAD FROM THE SKIN BY USING A CANNULA AND UNDERMINING THE TISSUE, BUT IT WAS NOT MOVING. ON (B)(6) 2024, THE SALES REPRESENTATIVE HAD ASKED THE HCP FOR PICTURES OF THE PATIENT. ON (B)(6) 2024, HCP PROVIDED THE PICTURES THAT WERE REQUESTED. A REQUEST WAS MADE TO THE MEDICAL DIRECTOR TO OBTAIN MEDICAL ADVICE ON THE CASE. ON (B)(6) 2024, THE MEDICAL DIRECTOR PROVIDED MEDICAL ADVICE WHICH WAS FORWARDED TO THE HCP. ON (B)(6) 2024, FOLLOW UP EMAIL WAS MADE TO THE HCP TO INQUIRE ABOUT THE STATUS OF THE PATIENT. ON OCTOBER 4TH, 2024, FOLLOW UP COMMUNICATION WAS MADE TO THE SALES REPRESENTATIVE TO INQUIRE ABOUT THE STATUS OF THE PATIENT FROM THE HCP. ON (B)(6) 2024, ANOTHER FOLLOW UP EMAIL WAS SENT TO THE HCP TO INQUIRE ABOUT THE STATUS OF THE PATIENT. HCP REPLIED THAT THE PATIENT IS DOING BETTER. ACCORDING TO THE HCP, THEY WERE ABLE TO CUT THE END OF THE THREAD WHICH WAS FOLDED OVER TWO WEEKS AGO. HCP STATED THAT THE THREAD HAD MOVED AGAIN AND THERE WAS NO VISIBLE BUMP ON THE PATIENT. HCP ALSO REPORTED THAT THE PATIENT'S SKIN IS BUNCH A LITTLE BIT WHERE THE THREAD SHIFTED. ON (B)(6) 2024, FOLLOW UP EMAIL WAS MADE TO THE HCP TO INQUIRE IF THERE WOULD BE A FOLLOW-UP BETWEEN THE HCP AND THE PATIENT. ON (B)(6) 2024, ANOTHER FOLLOW UP EMAIL WAS MADE TO THE HCP TO INQUIRE IF THERE WOULD BE A FOLLOW-UP BETWEEN THE HCP AND THE PATIENT. HCP REPLIED THAT THERE WILL BE A FOLLOW-UP. ON OCTOBER 17TH, 2024, EMAIL WAS SENT TO THE HCP TO FIND OUT ADDITIONAL INFORMATION AND TO NOTIFY THAT A FOLLOW UP ON THE PATIENT STATUS WILL BE CONDUCTED IN THE NEXT FEW WEEKS. THIS IS AN ONGOING INVESTIGATION. ADDITIONAL INFORMATION WILL BE PROVIDED IF AND WHEN IT IS AVAILABLE. UPDATE: ON (B)(6) 2024, A FOLLOW UP EMAIL WAS SENT TO THE HCP TO GATHER ADDITIONAL INFORMATION AND THE STATUS OF THE PATIENT. HCP DID NOT REPLY TO THE EMAIL. ON (B)(6) 2024, ANOTHER FOLLOW UP EMAIL WAS SENT TO THE HCP TO GATHER THE ADDITIONAL INFORMATION. ON (B)(6) 2024, A CALL WAS MADE TO THE SALES REPRESENTATIVE TO ASSIST IN CONTACTING THE HCP. ON (B)(6) 2024, A THIRD FOLLOW UP EMAIL WAS SENT TO THE HCP WITH NO RESPONSE. ON (B)(6) 2024, A FOURTH FOLLOW UP EMAIL WAS SENT TO THE HCP. HCP REPLIED WITH THE SAME INFORMATION THAT WAS PREVIOUSLY STATED ON (B)(6) 2024. ACCORDING TO THE HCP, THE PATIENT IS FINE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, HCP REPORTED TO THE SALES REPRESENTATIVE THAT A PDO THREAD WAS IMPLANTED ON THE PATIENT'S CHEEK. ACCORDING TO THE HCP, THE PATIENT EXPERIENCED A POP AFTER EATING ON THE LEFT SIDE AND NOW HAS A LITTLE NUMBNESS AND A LITTLE BUMP FORMED IN THE MARIONETTE AREA. HCP ALSO REPORTED THAT THEY TRIED TO REMOVE THE THREAD FROM THE SKIN BY USING A CANNULA AND UNDERMINING THE TISSUE, BUT IT WAS NOT MOVING. ON SEPTEMBER 8TH, 2024, THE SALES REPRESENTATIVE HAD ASKED THE HCP FOR PICTURES OF THE PATIENT. ON SEPTEMBER 9TH, 2024, HCP PROVIDED THE PICTURES THAT WERE REQUESTED. A REQUEST WAS MADE TO THE MEDICAL DIRECTOR TO OBTAIN MEDICAL ADVICE ON THE CASE. ON SEPTEMBER 10TH, 2024, THE MEDICAL DIRECTOR PROVIDED MEDICAL ADVICE WHICH WAS FORWARDED TO THE HCP. ON OCTOBER 1ST, 2024, FOLLOW UP EMAIL WAS MADE TO THE HCP TO INQUIRE ABOUT THE STATUS OF THE PATIENT. ON OCTOBER 4TH, 2024, FOLLOW UP COMMUNICATION WAS MADE TO THE SALES REPRESENTATIVE TO INQUIRE ABOUT THE STATUS OF THE PATIENT FROM THE HCP. ON OCTOBER 7TH, 2024, ANOTHER FOLLOW UP EMAIL WAS SENT TO THE HCP TO INQUIRE ABOUT THE STATUS OF THE PATIENT. HCP REPLIED THAT THE PATIENT IS DOING BETTER. ACCORDING TO THE HCP, THEY WERE ABLE TO CUT THE END OF THE THREAD WHICH WAS FOLDED OVER TWO WEEKS AGO. HCP STATED THAT THE THREAD HAD MOVED AGAIN AND THERE WAS NO VISIBLE BUMP ON THE PATIENT. HCP ALSO REPORTED THAT THE PATIENT'S SKIN IS BUNCH A LITTLE BIT WHERE THE THREAD SHIFTED. ON OCTOBER 7TH, 2024, FOLLOW UP EMAIL WAS MADE TO THE HCP TO INQUIRE IF THERE WOULD BE A FOLLOW-UP BETWEEN THE HCP AND THE PATIENT. ON OCTOBER 17TH, 2024, ANOTHER FOLLOW UP EMAIL WAS MADE TO THE HCP TO INQUIRE IF THERE WOULD BE A FOLLOW-UP BETWEEN THE HCP AND THE PATIENT. HCP REPLIED THAT THERE WILL BE A FOLLOW-UP. ON OCTOBER 17TH, 2024, EMAIL WAS SENT TO THE HCP TO FIND OUT ADDITIONAL INFORMATION AND TO NOTIFY THAT A FOLLOW UP ON THE PATIENT STATUS WILL BE CONDUCTED IN THE NEXT FEW WEEKS. THIS IS AN ONGOING INVESTIGATION. ADDITIONAL INFORMATION WILL BE PROVIDED IF AND WHEN IT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288841 DEMEDIOX ABSORBABLE POLYDIOXANONE SURGICAL SUTURE NEW DEMETECH CORPORATION PX2X45800100A16MTB C321-24 10652927784418

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention