BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1935322 · Received December 16, 2010

    Report

    Report Number
    2210968-2010-01695
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - RECURRENT HERNIA. CONCLUSIONS: 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 A PT UNDERWENT A LAPAROSCOPIC IPOM REPAIR OF A PRIMARY INCISIONAL/VENTRAL HERNIA UNDER GENERAL ANESTHESIA ON (B)(6) 2009. THE PT INDICATED ON THE 12 MONTH PT QUESTIONNAIRE THAT SHE NOTICED THE HERNIA HAD RECURRED. RECURRENCE DATE WAS (B)(6) 2010. THE PT INDICATED THAT SHE IS NOT TAKING ANY PAIN MEDS FOR THE HERNIA BUT SHE HAS SEEN A DOCTOR FOR PROBLEMS RELATED TO THIS HERNIA AND THAT A DOCTOR CONFIRMED RECURRENCE IN (B)(6) 2010. CURRENTLY, THERE IS NO REPORT OF REOPERATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention