BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL PRODUCT

    MDR report key: 2840309 · Received October 19, 2012

    Report

    Report Number
    9617613-2012-00234
    Event Type
    Injury
    Date Received
    October 19, 2012
    Report Date
    September 24, 2012
    Manufacturer
    COVIDENT, FORMERLY TISSUE
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A REPAIR PROCEDURE AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. ADDITIONAL INFORMATION FROM IMPORTER REPORT: IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, SUFFERING, HAS REQUIRED ADDITIONAL SURGERY, AND HAS SUSTAINED PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVICOL PRODUCT PELVICOL MESH FTL COVIDENT, FORMERLY TISSUE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R