BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMEDIOX

    MDR report key: 21292327 · Received February 3, 2025

    Report

    Report Number
    3007895168-2025-00001
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    January 10, 2025
    Report Date
    January 21, 2025
    Manufacturer
    DEMETECH CORPORATION
    Product Code
    NEW
    UDI-DI
    10652927721314
    PMA / PMN Number
    K082097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025, HCP REPORTED THAT THE PATIENT EXPERIENCED THREAD PROTRUSION 1 WEEK AFTER INSERTION. AN EMAIL WAS SENT TO THE HCP TO GATHER ADDITIONAL INFORMATION. ON (B)(6) 2025, A PHONE CALL WAS MADE TO THE HCP TO GATHER ADDITIONAL INFORMATION WITH NO RESPONSE. ANOTHER FOLLOW-UP EMAIL WAS SENT TO THE HCP WITH NO RESPONSE. ON (B)(6) 2025, A 2ND FOLLOW-UP EMAIL WAS SENT TO THE HCP. ON (B)(6) 2025, HCP REPLIED TO THE EMAIL PROVIDING THE INFORMATION REQUESTED. HCP REPORTED THAT THE PDO THREADS WERE IMPLANTED ON (B)(6)2024 AND WERE EXTRACTED ON (B)(6)2025. ACCORDING TO THE HCP, THE PATIENT'S SKIN HAS HEALED AS PER THE PATIENT'S FOLLOW UP VISIT ON (B)(6) 2025. HCP HAS STATED THE PATIENT HAS ANOTHER AREA OF CONCERN THAT WILL NEED A FOLLOW-UP AND HAS REQUESTED MEDICAL ADVICE FROM THE MEDICAL DIRECTOR. ON (B)(6) 2025, MEDICAL ADVICE WAS PROVIDED BY THE MEDICAL DIRECTOR WHICH WILL BE FORWARDED TO THE HCP. THIS IS AN ONGOING INVESTIGATION. ADDITIONAL INFORMATION WILL BE PROVIDED IF AND WHEN IT IS AVAILABLE. UPDATE: ON (B)(6) 2025, THE HCP HAD REQUESTED ADDITIONAL INFORMATION FOR TRAINING WHICH THEY WERE GUIDED TO CONTACT THE SALES REPRESENTATIVE. ON (B)(6) 2025, A FOLLOW-UP EMAIL WAS SENT TO THE HCP TO INQUIRE ABOUT THE STATUS OF THE PATIENT. ON (B)(6), 2025, A PHONE CALL WAS MADE TO THE HCP TO INQUIRE ABOUT THE STATUS OF THE PATIENT. ON (B)(6) 2025, THE HCP RETURNED THE PHONE CALL AND STATED THAT THE PATIENT WAS DOING PERFECTLY FINE AND THAT NO FURTHER FOLLOW-UP WOULD BE NEEDED. HCP HAS BEEN INFORMED THAT THE CASE IS NOW CLOSED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, HCP REPORTED THAT THE PATIENT EXPERIENCED THREAD PROTRUSION 1 WEEK AFTER INSERTION. AN EMAIL WAS SENT TO THE HCP TO GATHER ADDITIONAL INFORMATION. ON (B)(6) 2025, A PHONE CALL WAS MADE TO THE HCP TO GATHER ADDITIONAL INFORMATION WITH NO RESPONSE. ANOTHER FOLLOW-UP EMAIL WAS SENT TO THE HCP WITH NO RESPONSE. ON (B)(6) 2025, A 2ND FOLLOW-UP EMAIL WAS SENT TO THE HCP. ON (B)(6) 2025, HCP REPLIED TO THE EMAIL PROVIDING THE INFORMATION REQUESTED. HCP REPORTED THAT THE PDO THREADS WERE IMPLANTED ON (B)(6) 2024 AND WERE EXTRACTED ON (B)(6) 2025. ACCORDING TO THE HCP, THE PATIENT'S SKIN HAS HEALED AS PER THE PATIENT'S FOLLOW UP VISIT ON (B)(6) 2025. HCP HAS STATED THE PATIENT HAS ANOTHER AREA OF CONCERN THAT WILL NEED A FOLLOW-UP AND HAS REQUESTED MEDICAL ADVICE FROM THE MEDICAL DIRECTOR. ON (B)(6) 2025, MEDICAL ADVICE WAS PROVIDED BY THE MEDICAL DIRECTOR WHICH WILL BE FORWARDED TO THE HCP. 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
    1208126 DEMEDIOX ABSORBABLE POLYDIOXANONE SURGICAL SUTURE NEW DEMETECH CORPORATION PX2X29800100A16MB E147-24 10652927721314

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention