BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-LINE HERNIA MESH

    MDR report key: 17740431 · Received September 13, 2023

    Report

    Report Number
    3017492634-2023-00002
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    May 10, 2023
    Report Date
    September 11, 2023
    Manufacturer
    DEEP BLUE MEDICAL ADVANCES, INC.
    Product Code
    FTL
    PMA / PMN Number
    K221556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATIONS INCLUDING REVIEW OF MANUFACTURING RECORDS, COMPLAINT RECORDS, AND COMMUNICATIONS WITH THE SURGEON WERE CONDUCTED. IS WAS DETERMINED BY THE DOCTOR THROUGH CULTURING TO BE AN INFECTION AT THE SITE OF THE INCISION AND WAS NOT IMPLICATING THE PRODUCT.

    Description of Event or Problem · 0

    A SURGEON AUTHORED A PAPER THAT WAS SENT TO (B)(6), CEO AND DR. (B)(6), CMO TO REVIEW THE DRAFT. IN THE PAPER THE AUTHOR MENTIONS TWO CASES WHERE AN INFECTION DEVELOPED, AND THE IMPLANT WAS REMOVED. THIS WAS DISCOVERED ON (B)(6) 2023. THE SURGEON STATED THAT; IN OUR SERIES OF 40 PATIENTS, WE HAD 2 CASES OF INFECTION THAT REQUIRED REMOVAL OF THE MESH. ONE PATIENT ELECTED TO DISCONTINUE MANAGEMENT OF HER DIABETES POST SURGICALLY. THE SECOND PATIENT HAD A PAST HISTORY OF HTN AND DEVELOPED MESH EXPOSURE ALONG HER INFRAUMBILICAL REGION AS A RESULT OF DEHISCENCE. BOTH PATIENTS WERE CULTURE POSITIVE FOR S. AUREUS, AND RESPONDED WELL TO WASH OUT, REMOVAL OF MESH AND ONE WEEK OF ORAL ANTIBIOTICS. BOTH WERE 100% SATISFIED WITH THEIR CLINICAL RESULTS AND DID NOT REQUEST REPLACEMENT OF THE MESH. PATIENTS DID REPORT A SIGNIFICANT FEELING OF ANTERIOR ABDOMINAL PRESSURE, BUT NONE SUFFERED FROM CLINICAL COMPARTMENT SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84228 T-LINE HERNIA MESH HERNIA MESH FTL DEEP BLUE MEDICAL ADVANCES, INC. TL3007 A2112005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other