BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM MESH

    MDR report key: 3212886 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12578
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    April 14, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED CONCURRENTLY WITH LAVH.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CHRONIC CRAMPING, INCONTINENCE, FREQUENCY AND URGENCY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED CONCURRENTLY WITH PEREYRA URETHROPEXY, INCIDENTAL APPENDECTOMY AND TRANSFUSION OF PACKED CELLS DUE TO POP, SUI, MENORRHAGIA, DYSPAREUNIA AND CHRONIC PELVIC PAIN. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED STABBING ABDOMINAL PAIN THAT CAUSES HER TO ¿DOUBLE OVER¿ AT TIMES, PAIN THAT FEELS LIKE SOMETHING IS TEARING INSIDER HER ABDOMEN, RECURRENT UTIS, YELLOWISH DISCHARGE, URINARY RETENTION, LOW BACK PAIN THAT RADIATES TO HER HIPS AND LEGS, CONSTIPATION, DEPRESSION AND ANXIETY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED DUE TO SUI, DYSPAREUNIA, CHRONIC PELVIC PAIN. IT WAS REPORTED THAT PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2014 DUE TO DYSPAREUNIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. 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
    314134 PROLENE HERNIA SYSTEM MESH MESH, SURGICAL, SYNTHETIC FTL ETHICON INC. UNK DCB046

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention