BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLITE ULTRA

    MDR report key: 7455764 · Received April 24, 2018

    Report

    Report Number
    3011175548-2018-00392
    Event Type
    Death
    Date Received
    April 24, 2018
    Report Date
    April 24, 2018
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K930669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE INVESTIGATION WAS NOT ABLE TO BE PERFORMED AS NO PRODUCT NUMBER, LOT NUMBER OR SAMPLE WAS PROVIDED. PER THE ARTICLE THE RETROMUSCULAR INSERTION OF SYNTHETIC MESH AT THE TIME OF FORMATION OF AN END-COLOSTOMY REDUCED THE RISK OF PSH.

    Description of Event or Problem · 1

    ARTICLE RECEIVED TITLED "PROPHYLACTIC MESH AT END COLOSTOMY CONSTRUCTION REDUCES PARASTOMAL HERNIA RATE: A RANDOMIZED TRIAL". THE ARTICLE COMPARED THE RESULTS OF USING MESH OR NO MESH AT THE TIME OF FORMATION OF A COLOSTOMY WITH THE CLINICAL IDENTIFICATION OF PSH AS THE PRIMARY OUTCOME. PER THE STUDY 2 DEATHS IN OCCURRED IN THE THREE YEAR FOLLOW UP PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298511 PROLITE ULTRA MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death