BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 21741482 · Received April 1, 2025

    Report

    Report Number
    1416980-2025-01698
    Event Type
    Injury
    Date Received
    April 1, 2025
    Report Date
    April 1, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UNIQUE IDENTIFIER (UDI) #: THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN; THEREFORE, THE UDI NUMBER COULD NOT BE COMPILED. H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DURING A SURVEY, AN UNSPECIFIED HEALTHCARE WORKER RESPONDED ¿4-7%" PATIENTS EXPERIENCE STAPLE LINE BLEEDING¿ WHEREIN PSD-V ¿ LINEAR STANDARD/LINEAR THIN WITH GEL WAS UTILIZED DURING THE REINFORCEMENT OF STAPLE LINES FOR UNSPECIFIED GASTRIC, INCLUSIVE OF SMALL BOWEL PROCEDURES. THE RESPONDENT ADDED " NOT SURE OF THE EXACT PERCENTAGE BUT SEEMS LIKE A SMALL AMOUNT OF BLEEDING OCCURS ON EVERY FEW FIRINGS OF THE STAPLER AND HAS TO BE CAUTERIZED OR SUTURED¿. THIS EVENT LIKELY REQUIRED SURGICAL INTERVENTION IN ORDER TO PRECLUDE PERMANENT IMPAIRMENT. THE RESPONDENT ANSWERED ANONYMOUSLY; THEREFORE, FOLLOW UP INFORMATION WAS NOT ABLE TO BE OBTAINED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055322 NI MESH, SURGICAL FTM BAXTER HEALTHCARE CORPORATION NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention