BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 10465931 · Received August 28, 2020

    Report

    Report Number
    1416980-2020-05261
    Event Type
    Injury
    Date Received
    August 28, 2020
    Report Date
    October 5, 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 · 0

    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.

    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 REOPERATIONS DUE TO STAPLE LINE LEAKS OR STAPLE LINE BLEEDING AFTER USING PERI-STRIPS WITH GEL FOR THE REINFORCEMENT OF STAPLE LINES DURING GASTRIC, INCLUSIVE OF SMALL BOWEL SURGICAL PROCEDURES WAS 1-3%. THE PHYSICIAN REPORTED ¿ABOUT 1/2 OF THOSE WITH LEAKS NEEDED REOP" (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
    929935 NI MESH, SURGICAL FTM BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other