BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2844351 · Received November 26, 2012

    Report

    Report Number
    2210968-2012-07550
    Event Type
    Injury
    Date Received
    November 26, 2012
    Report Date
    November 10, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT MENORRHAGIA AND PELVIC FLOOR RELAXATION WITH SYMPTOMATIC RECTOCELE. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PERFORMED DURING MESH IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IN-OFFICE MESH EXCISION ON (B)(6) 2004 AND AMP: (B)(6) 2004 AND ON(B)(6) 2004. THE PATIENT UNDERWENT A SURGICAL PROCEDURE FOR MESH EXPLANT DUE TO MESH ERODED AND INJURED RECTUM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF BSO AND POSTERIOR REPAIR WITH CORRECTION OF RECTOCELE DURING MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2004, ALONG WITH POSTERIOR REPAIR REVISION AND PERINEOPLASTY DUE TO MESH EROSION.

    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). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA TDB850

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention