BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SOFRADIM PRODUCT

    MDR report key: 1811104 · Received August 13, 2010

    Report

    Report Number
    9615742-2010-00034
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    January 7, 2010
    Report Date
    July 22, 2010
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE RPTR: THE PT EXPERIENCED A RECURRENT HERNIA IN (B)(6) 2010. REPORTED VIA (B)(6). ADDITIONAL INFO HAS BEEN REQUESTED.

    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