BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH

    MDR report key: 1942572 · Received December 23, 2010

    Report

    Report Number
    2210968-2010-01735
    Event Type
    Injury
    Date Received
    December 23, 2010
    Report Date
    November 29, 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) - INFECTION. CONCLUSIONS: 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 OPEN REPAIR OF A PRIMARY INCISIONAL/VENTRAL HERNIA UNDER GENERAL ANESTHESIA ON (B)(6) 2010. THE PT WAS DISCHARGED ON (B)(6) 2010, WITH NO ISSUES NOTED. A POST OPERATIVE INFECTION WAS REPORTED IN (B)(6) 2010. VACUUM ASSISTED CLOSURE (VAC) WAS STARTED ON (B)(6) 2010. THE INFECTION 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 66 YR Required Intervention