BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3140350 · Received May 31, 2013

    Report

    Report Number
    2210968-2013-06311
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    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 THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT A VENTRAL HERNIA ON (B)(6) 2000 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING PAIN AND NAUSEA , VOMITING AND FEVER ON (B)(6) 2012. SHE UNDERWENT SURGERY ON (B)(6) 2012, WHICH REVEALED A BOWEL OBSTRUCTION AND INTRA-ABDOMINAL ADHESIONS OF MESH TO THE ANTERIOR ABDOMINAL WALL. THE PATIENT WAS REPORTEDLY ADMITTED TO HOSPITAL WITH ANOTHER SMALL BOWEL OBSTRUCTION ON (B)(6) 2013, REQUIRING A SUBSEQUENT SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241780 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention