BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VYPRO MESH

    MDR report key: 1900012 · Received November 9, 2010

    Report

    Report Number
    2210968-2010-01481
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    July 3, 2010
    Report Date
    October 9, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K002672
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (PAIN OCCURRED). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN INDIRECT INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2010 AND MESH WAS PLACED. AFTER THE SURGERY, THE PT HAD AN ACHE AND THE WOUND APPEARED RED AND SWOLLEN. THEN THE SURGEON STUDIED THE SURGERY VIDEO AND NOTICED THE ACHE WAS DUE TO A PINCHED NERVE THAT OCCURRED DURING THE PROCEDURE. ON (B)(6) 2010, THE PT UNDERWENT A SECOND SURGERY TO REMOVE THE SUTURE WHICH HE FELT WAS TRAPPING THE NERVE. THE MESH WAS LEFT IN PLACE. NOW THE PT IF FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VYPRO MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention