BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA SYSTEM

    MDR report key: 4006573 · Received August 13, 2014

    Report

    Report Number
    2210968-2014-11363
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    January 28, 2009
    Report Date
    July 24, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K071249
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INGUINAL HERNIA REPAIR ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. A FEW DAYS POST-OP, THE PATIENT EXPERIENCED ITCHING, CRAMPING AND ABDOMINAL PAIN. DURING FOLLOW-UP, THE SURGEON OPINED THE PROBLEM AS ¿JOCK ITCH¿. THE PATIENT HAS SEEN MULTIPLE PHYSICIANS AND HAS REQUESTED REMOVAL OF THE MESH, BUT NONE OF THE SURGEONS WOULD REMOVE IT. THE PATIENT IS BEING TREATED BY A DERMATOLOGIST WHO OPINES THAT THE PATIENT IS HAVING AN ALLERGIC REACTION TO THE MESH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481389 ULTRAPRO HERNIA SYSTEM MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK AJ8DTWA0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention