BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMACOL 10X28 1.5MM

    MDR report key: 3071008 · Received April 3, 2013

    Report

    Report Number
    9617613-2013-00153
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 23, 2012
    Report Date
    March 6, 2013
    Manufacturer
    COVIDIENT, FORMERLY TISSUE...
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: THE PT HAD SURGERY ON (B)(6) 2012. ON (B)(6) 2012, THE PT PRESENTED WITH A SEROMA. THIS IS ONGOING. THE PT IS UNDER OBSERVATION FOR THE SEROMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135515 PERMACOL 10X28 1.5MM PERMACOL MESH FTL COVIDIENT, FORMERLY TISSUE... 10B13-5

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR (B)(4), PERMACOL 10X15 1.5MM, LOT#: 11B07-9