BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA SYSTEM

    MDR report key: 1855145 · Received September 30, 2010

    Report

    Report Number
    2210968-2010-01205
    Event Type
    Injury
    Date Received
    September 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K071249
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (HERNIA RECURRED): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. POST-OPERATIVELY 18-24 MONTHS, THE PATIENT RETURNED WITH A SUSPECTED RECURRENT INGUINAL HERNIA. LAPAROSCOPIC INVESTIGATION WAS PLANNED FOR (B)(6)2010. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPRO HERNIA SYSTEM MESH, SURGICAL FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention