BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX PROGRIP PRECUT W/FLAP LEFT SIDE

    MDR report key: 1815429 · Received August 20, 2010

    Report

    Report Number
    9615742-2010-00035
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    April 1, 2010
    Report Date
    July 26, 2010
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K081050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON 08/20/2010.

    Description of Event or Problem · 1

    PROCEDURE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: ON (B)(6) 2010, THE PATIENT EXPERIENCED INFECTION AND TEMPERATURE RANGING FROM 102-103 DEGREES F POST OPERATIVELY. NO BLOOD LOSS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX PROGRIP PRECUT W/FLAP LEFT SIDE SOFRADIM MESH FTL SOFRADIM PRODUCTION SJK00235

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other