BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3020530 · Received March 26, 2013

    Report

    Report Number
    2210968-2013-02910
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO PELVIC ORGAN PROLAPSE AND PELVIC PAIN. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS, ADHESIONS AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT INCIDENTAL CYSTOTOMY, UNREPAIRED; MULTIPLE LYSIS OF ADHESIONS ON (B)(6) 2011 DUE TO ABDOMINAL PAIN, CYSTOCELE AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC LYSIS OF ADHESIONS, LAPAROSCOPIC REMOVAL OF ABDOMINAL SACROCOLPOPEXY MESH; CYSTOSCOPY; PARTIAL REMOVAL OF SLING ON (B)(6) 2013 DUE TO PELVIC PAIN, URINARY FREQUENCY, URGENCY AND ABDOMINAL PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY WITH VAGINAL SLING-AUTOLOGOUS FASCIAL ON (B)(6) 2013 DUE TO STRESS URINARY INCONTINENCE. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT URETHROLYSIS AND CYSTOSCOPY ON (B)(6) 2013 DUE TO RETENTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2002 AND MESH WAS IMPLANTED. ON (B)(6) 2011, OMNISURE URETHRAL SLING - COLOPLAST/MPATHY MED WAS IMPLANTED. IT WAS REPORTED THAT SHE 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123367 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA RCE837

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention