BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH

    MDR report key: 4434248 · Received January 20, 2015

    Report

    Report Number
    2210968-2015-00427
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    December 11, 2013
    Report Date
    January 6, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K061533
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, IT WAS REPORTED THAT MORRISON FORCEPS WERE USED TO LIFT THE ABDOMINAL WALL AND TO POSITION THE MESH. THE SURGEON OPINED THAT SOMETIME MORE FORCE IS NECESSARY THAN OTHER TIMES BUT THEY CANNOT RECALL HOW DIFFICULT THIS WAS. IT WAS REPORTED THAT THE PATIENT WORKS AS A BOILER MAKER AND PRIOR TO THE RECURRENCE WAS DOING HEAVY WORK. THE RECURRENCE WAS AT THE SUPERIOR MARGIN WHERE THE MESH HAD FAILED TO INCORPORATE. DURING THE RE-OPERATION, THE MESH WAS EXPLANTED AND A NEW MESH WAS IMPLANTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MID-ABDOMINAL OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2013 AND MESH WAS IMPLANTED PRE-PERITONEAL. APPROXIMATELY 6-MONTHS POST-OPERATIVELY, THE PATIENT REPORTED THE HERNIA RECURRED. ON (B)(6) 2013, THE PATIENT WAS DIAGNOSED WITH RECURRENCE. THE PATIENT UNDERWENT REOPERATION AND REPAIR WITH MESH. THE SURGEON OPINED THE PATIENT SUSTAINED A RECURRENCE WITH A FAILURE OF THE MESH TO INCORPORATE AT THE SUPERIOR MARGIN. IT WAS REPORTED THE EVENT IS NOTED AS RESOLVED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46681 PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention