BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDO MAX SMOOTH THREAD

    MDR report key: 23715729 · Received December 4, 2025

    Report

    Report Number
    MW5179858
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    October 10, 2025
    Report Date
    December 3, 2025
    Manufacturer
    PDO MAX
    Product Code
    NEW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM SUBMITTING A REPORT REGARDING THE USE OF AN EXPIRED MEDICAL DEVICE (PDO MAX SMOOTH THREAD) DURING A COSMETIC PROCEDURE PERFORMED ON (B)(6) 2025, AT (B)(6), LOCATED AT (B)(6) THE PRODUCT¿S PACKAGING SHOWS AN EXPIRATION DATE OF 6/25/2025, INDICATING THAT IT WAS EXPIRED AT THE TIME OF USE. I HAVE ATTACHED A PHOTO OF THE PRODUCT AND THE TREATMENT INVOICE AS EVIDENCE. FOLLOWING THE PROCEDURE, I HAVE EXPERIENCED BLURRY VISION IN MY RIGHT EYE, CORRESPONDING TO THE TREATED AREA. WHILE I AM MONITORING THE SYMPTOM, I AM CONCERNED ABOUT POTENTIAL SAFETY RISKS DUE TO THE USE OF EXPIRED PRODUCT MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2806779 PDO MAX SMOOTH THREAD SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW PDO MAX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown