BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETENE LIGHT PP 15X10CM X3

    MDR report key: 2250078 · Received September 9, 2011

    Report

    Report Number
    9615742-2011-00085
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    June 1, 2010
    Report Date
    August 10, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: SURGERY DATE WAS ON (B)(6) 2010 AND ON (B)(6) 2011, THE PATIENT EXPERIENCED A RECURRENT RIGHT INGUINAL HERNIA WHICH WAS REPAIRED BY SURGERY. RELATION TO THE DEVICE IS PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETENE LIGHT PP 15X10CM X3 SOFRADIM LIGHT MESH FTL SOFRADIM PRODUCTION SIK00664

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other