BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2973238 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01594
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. SIX WEEKS POST OPERATION THE PATIENT WAS FOUND TO HAVE VAGINAL WALL EROSION AND UNDERWENT EXCISION SURGERY ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2008. THE PATIENT CONTINUED TO EXPERIENCE PAIN, EROSION, DYSPAREUNIA AND BLEEDING. THE PATIENT WAS HOSPITALIZED IN (B)(6) 2012 DUE TO DYSPNEA, ANEMIA AND HEADACHE ALL ALLEGEDLY CAUSED BY THE MESH EROSION. THE PATIENT REFUSED BLOOD TRANSFUSIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2012. THE PATIENT UNDERWENT AN ADDITIONAL MESH REMOVAL SURGERY ON (B)(6) 2012 ALONG WITH BLADDER RECONSTRUCTION AND REPAIR OF BLADDER LESIONS. THE PATIENT IS CURRENTLY FEELING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT THIRD DEGREE CYSTOCELE, SECOND DEGREE UTERINE PROLAPSE AND CYSTOCELE. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF ANTERIOR AND POSTERIOR COLPORRHAPHY AND CYSTOSCOPY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MULTIPLE PELVIC FLOOR SURGERIES. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2008 DUE TO EROSION OF VAGINAL MESH. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 DUE TO EROSION, PELVIC PAIN, DYSPAREUNIA, AND RECURRENT CYSTOCELE. THE PATIENT ALSO UNDERWENT SURGERY ON THE SAME DAY FOR BLADDER RECONSTRUCTION AND REPAIR OF BLADDER LESIONS FROM SYNTHETIC MESH, AND ANTERIOR REPAIR WITH PARAVAGINAL REPAIR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED. SIX WEEKS POST OP, SHE WAS FOUND TO HAVE VAGINAL WALL EROSION, AND HAD EXCISION SURGERY ON (B)(6) 2008. THE PATIENT CONTINUED TO EXPERIENCE PAIN, EROSION, DYSPAREUNIA AND BLEEDING. SHE WAS HOSPITALIZED IN (B)(6) 2012, DUE TO DYSPNEA, ANEMIA AND HEADACHE, ALLEGEDLY DUE TO MESH EROSION. REFUSED BLOOD TRANSFUSIONS, PATIENT UNDERWENT AN ADDITIONAL MESH REMOVAL SURGERY ON (B)(6) 2012 ALONG WITH BLADDER RECONSTRUCTION AND REPAIR OF BLADDER LESIONS. SHE IS CURRENTLY FEELING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76174 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON INC NA 3049991

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention