BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA PLUG

    MDR report key: 2072200 · Received April 28, 2011

    Report

    Report Number
    2210968-2011-00537
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    June 18, 2009
    Report Date
    April 6, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K070224
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/28/2011. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR ON (B)(6) 2009. THE PATIENT EXPERIENCED PAIN AT THE SURGERY SITE POSTOPERATIVELY. A CT SCAN WAS DONE (B)(6) 2009 AND A RECURRENT HERNIA WAS DIAGNOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPRO HERNIA PLUG MESH, SURGICAL FTL ETHICON NA AD8DTBZ0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention