BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED* MULTI-LAYER LAMINATE MESH

    MDR report key: 2892226 · Received January 2, 2013

    Report

    Report Number
    2210968-2013-00014
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 13, 2012
    Manufacturer
    ETHICON, INC
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT ABDOMINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF A HERNIA REPAIR AND LYSIS OF ADHESIONS PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT ON (B)(6) 2011 PATIENT UNDERWENT LYSIS OF ADHESIONS, SMALL BOWEL RESECTION, REMOVAL OF INFECTED MESH, REPAIR OF VENTRAL HERNIA WITH DUAL MESH, AND DEBRIDEMENT OF MUSCLE AND FASCIA DUE TO INFECTED ABDOMINAL WALL MESH. IT WAS FURTHER REPORTED THAT ON (B)(6) 2012 PATIENT UNDERWENT INCISION AND DRAINAGE PROCEDURE DUE TO INFECTED ABDOMINAL WOUND. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4) - ADHESIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.IN ADDITION, 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 A VENTRAL HERNIA PROCEDURE ON (B)(6) 2011 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED UNSPECIFIED INJURIES FOLLOWING THE PROCEDURE, WHICH WERE ASCERTAINED ON (B)(6) 2011. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203 PROCEED* MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC NA DCG133

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention