BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH

    MDR report key: 1810023 · Received August 12, 2010

    Report

    Report Number
    2210968-2010-00913
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    January 26, 2010
    Report Date
    July 12, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - HEMATOMA OCCURRED. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A PRIMARY, LEFT INDIRECT INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2010. THE PROCEDURE WAS LAPAROSCOPIC WITH TRANS-ABDOMINAL PRE-PERITONEAL PLACEMENT. THE WOUND DISCHARGE SUMMARY DATED (B)(6) 2010, IS UNREMARKABLE. POST-OPERATIVELY, THE PT DEVELOPED A HEMATOMA ON (B)(6) 2010. THE EVENT WAS TREATED BY PUNCTURE/ASPIRATION AND ANTIPHLOGISTICS. THE EVENT WAS RESOLVED AS OF (B)(6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention