BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SOFRADIM PRODUCT

    MDR report key: 2010776 · Received January 6, 2010

    Report

    Report Number
    9615742-2011-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2010
    Report Date
    December 13, 2010
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    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 TYPE: HERNIA. ACCORDING TO THE REPORTER: THE PT WAS SEEN FOR MULTIPLE HERNIAS. MESH WAS UTILIZED FOR REPAIR OF DAMAGED AREA. FIVE MONTHS POST-OPERATIVELY, THE PT PRESENTED WITH SEVERE ABDOMINAL PAIN THAT WORSENED. SHE NOTIFIED SURGEON FOR ONGOING DISCOMFORT. CURRENT DIAGNOSIS IS GASTROPARESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SOFRADIM PRODUCT SOFRADIM MESH FTL SOFRADIM PRODUCTION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1