BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 10459422 · Received August 27, 2020

    Report

    Report Number
    1416980-2020-05233
    Event Type
    Injury
    Date Received
    August 27, 2020
    Report Date
    August 27, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT IS AN UNKNOWN BAXTER PERI-STRIPS PSD-V WITH GEL. 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 · 1

    IT WAS REPORTED FROM AN ANONYMOUS SURVEY RESULT THAT THE PERCENTAGE OF PATIENTS THAT HAD LEAKS OR BLEEDS FOLLOWING SURGERY USING PERI-STRIPS WITH GEL FOR THE REINFORCEMENT OF STAPLE LINES DURING BARIATRIC SURGICAL PROCEDURES WAS 1-3%. THE PHYSICIAN REPORTED ¿1-3% LEAK RATE IS THE BASELINE LEAK RATE FOR BARIATRIC SURGERY IN GENERAL (FOR ME) WITHOUT ANY REINFORCEMENT OF STAPLE LINE THIS WOULD BE LOWER BUT MANY PT COME TO ME AND DO NOT WANT ANY 'FOREIGN MATERIAL' USED IN THEIR SURGERY SO THAT EFFECT MY LEAK RATE. I AM SURE IT WOULD BE LOWER IF EVERY PT HAD STAPLE LINE REINFORCEMENT¿ (NO FURTHER DETAILS). AT THE TIME OF THIS REPORT, NO FURTHER DETAIL WAS PROVIDED REGARDING IF HOSPITALIZATION WAS REQUIRED, TREATMENT FOR THE EVENT OR THE PATIENT¿S OUTCOME. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923072 NI MESH, SURGICAL FTM BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other