BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDO MAX THREADS LEVO AND SMUTH

    MDR report key: 15113919 · Received July 27, 2022

    Report

    Report Number
    3015289316-2022-00001
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    July 11, 2022
    Report Date
    July 27, 2022
    Manufacturer
    PDO MAX
    Product Code
    NEW
    UDI-DI
    00850018324304
    PMA / PMN Number
    K190245
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFECTION HAPPENED AFTER THE PROCEDURE. UNSURE IF REACTION IS FROM PATIENT'S CLOTTING DISORDER AND AUTOIMMUNE DISORDER, UNSTERILE PROCEDURE OR THREADS THEMSELVES. NO OTHER ISSUES REPORTED REGARDING THREADS FROM THIS LOT.

    Description of Event or Problem · 0

    DURING A PROCEDURE THE PATIENT RECEIVED LEVO 19X100MM BARBED THREADS AND SMUTH S 30GX38MM SMOOTH THREADS. THE PATIENT NOTIFIED THE PROVIDER ON 7/11/22 THAT SHE HAD SOME SWELLING, SORENESS AND SOME DISCHARGE AFTER THE PROCEDURE. THE PROVIDER ALSO INJECTED PRP AT THE SAME TIME AS THREADS. PATIENT'S CONDITION WORSENED NEEDING HOSPITALIZATION. INFECTION PROGRESSED TO NECROTIZING FASCITIS AND REQUIRED 4-DAY HOSPITALIZATION STAY. THE MEDICAL DIRECTOR CALLED AND SPOKE WITH THE TREATING PHYSICIAN AND REVIEWED TREATMENT PLAN AND HOSPITALIZATION RECORDS. IT IS NOT BELIEVED THAT INFECTION WAS CAUSED BY THE THREADS THEMSELVES BUT THE PATIENT'S UNDERLYING MEDICAL HISTORY CONTRIBUTING TO THE POOR OUTCOME. THE PATIENT HAS SEVERAL MEDICAL CONDITIONS THAT ARE CONTRAINDICATIONS OUTLINED IN THE PROTOCOLS. THE PROTOCOLS WERE REVIEWED BY THE MEDICAL DIRECTOR WITH THE TREATING PHYSICIAN, AND THEY WILL CONTINUE TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163414 PDO MAX THREADS LEVO AND SMUTH ABSORBABLE POLYDIOXANONE SURGICAL SUTURE NEW PDO MAX PM19100L-FE-BP YR21120182 00850018324304

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Hospitalization