BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH

    MDR report key: 3242796 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14159
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 18, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K061533
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PATIENT WAS TREATED WITH INTRA-OPERATIVE FLUCLOXACILLIN. NO ROUTINE POST OP ANTIBIOTICS WERE GIVEN AND CLINDAMYCIN WAS USED PRE-DRAINAGE. THE WOUND WAS WASHED OUT ON (B)(6) 2013 AND LEFT OPEN WITH A VAC DRESSING TO HEAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. ON (B)(6) 2013, THE SURGEON ASPIRATED 30 ML OF FLUID FROM THE WOUND. THE PATIENT DEVELOPED A SURGICAL SITE INFECTION ON (B)(6) 2013, SO THE WOUND WAS DRAINED AND WASHED OUT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342399 PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention