BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA SYSTEM

    MDR report key: 2971568 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01398
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 30, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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 A BILATERAL INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012 AND MESH WAS IMPLANTED. THE PATIENT DEVELOPED PAIN AND INFLAMMATION AT THE SITE OF THE RIGHT INCISION. HE WAS READMITTED TO THE HOSPITAL FOR CELLULITIS OF THE RIGHT INCISION. HE WAS TREATED WITH ANTIBIOTICS, WOUND DRAINAGE THERAPY, MIRABILITE AND PHYSICAL THERAPY. THE PATIENT HAS IMPROVED BUT IS STILL CURRENTLY HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76728 ULTRAPRO HERNIA SYSTEM MESH, SURGICAL FTL ETHICON, INC. NA EH8JPCA0

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R