BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCO VENTRAL PATCH 6C

    MDR report key: 3761137 · Received December 31, 2013

    Report

    Report Number
    9615742-2013-02492
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    September 26, 2013
    Report Date
    December 16, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K120506
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: THIS PT, WHO WAS PART OF A CLINICAL STUDY, HAD HERNIA SURGERY ON (B)(6) 2013. PT PRESENTED WITH WOUND INFECTION. LAB TEST SHOWED GROWTH OF STAPH AUREUS. PT WAS PRESCRIBED TBL. DICLOXACILLIN. INFECTION HAS RESOLVED AS OF (B)(6) 2013. ACCORDING TO THE REPORTER, RELATIONSHIP TO THE DEVICE IS UNK/IMPOSSIBLE TO DETERMINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682517 PCO VENTRAL PATCH 6C PARIETEX MESH FTL SOFRADIM PRODUCTION PNB99995

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR