BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDO THREAD

    MDR report key: 21134298 · Received January 12, 2025

    Report

    Report Number
    3015289316-2024-00002
    Event Type
    Injury
    Date Received
    January 12, 2025
    Date of Event
    December 5, 2024
    Report Date
    December 12, 2024
    Manufacturer
    PDO MAX
    Product Code
    NEW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NONE.

    Description of Event or Problem · 0

    RECEIVED A COMPLAINT FROM A PROVIDER THAT A PATIENT MAY HAVE IN INFECTION AT THE TREATMENT SITE. THE NOTES FROM THE PROVIDER ARE COPIED HERE "RIGHT CHEEK HAD SOME PUCKERING AFTER TREATMENT INITIALLY; PATIENT CANCELLED FOLLOW UP IN 4 WEEKS; PRESENTED RECENTLY WITH BULGING ON RIGHT SIDE ONLY WHERE LIFTING THREAD WAS PLACED AND HAD INITIAL PUCKERING. CLIENT IS A SELF PROCLAIMED "PICKER" AND MAY HAVE PICKED AT THIS LOCATION. PATIENT WAS PRESCRIBED A STEROID DOSE PACK AND STARTED CEPHLEXIN 500 MG PRO BID."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511992 PDO THREAD SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW PDO MAX LEVO 19GX100MM YR24070002

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention