BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT

    MDR report key: 4914826 · Received July 15, 2015

    Report

    Report Number
    1219930-2015-00543
    Event Type
    Injury
    Date Received
    July 15, 2015
    Report Date
    July 10, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON ADDITIONAL INFORMATION RECEIVED, IT HAS BEEN DETERMINED THAT THE PRODUCT WAS MANUFACTURED AT ANOTHER FACILITY; THEREFORE, A REPORT HAS BEEN GENERATED UNDER MANUFACTURING REPORT # 9617613-2016-00007 (REFERENCE NUMBER: (B)(4)) TO CAPTURE THE CHANGE. NO FURTHER INFORMATION WILL BE REPORTED UNDER THIS MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PRODUCT PROMOTED INFLAMMATION OF THE PELVIC TISSUE AND CONTRIBUTED TO THE FORMATION OF SEVERE ADVERSE REACTIONS TO THE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458303 UNKNOWN MESH PRODUCT MESH FTL COVIDIEN, FORMERLY US SURGICAL A DIVISON

    Patients

    Seq Age Sex Outcome Treatment
    1 Other