BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENEMESH

    MDR report key: 3234012 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13702
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    October 24, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K001122
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY/BOWEL PROBLEMS, AND OTHER PROBLEMS. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 09/18/2013.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LAPAROSCOPIC TAKEDOWN OF SACROCOLPOPEXY MESH, REMOVAL OF VAGINAL PORTION OF MESH, SACROSPINOUS LIGAMENT FIXATION, POSTERIOR REPAIR AND CYSTOSCOPY ON (B)(6) 2013 FOR BACK PAIN, PELVIC PAIN AND HISTORY OF SACROCOLPOPEXY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335074 PROLENE POLYPROPYLENEMESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention