BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3162216 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10079
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    April 3, 2004
    Report Date
    May 17, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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 A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 1994 AND MESH WAS IMPLANTED. THE PATIENT REQUIRED SURGERY ON (B)(6) 2004 TO REMOVE A PORTION OF THE MESH DUE TO SCAR TISSUE AND MESH SHRINKAGE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262032 PROLENE POLYPROPYLENE MESH MESH SURGICAL POLYMERIC FTL ETHICON INC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention