BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3211455 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12398
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    April 12, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT URETHRAL CALIBRATION AND BLADDER BIOPSY WITH FULGURATION ON (B)(6) 2012 DUE TO CHRONIC CYSTITIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT VAGINAL RECONSTRUCTION, ABDOMINAL REPAIR OF RECTOCELE, PLACEMENT OF OMENTAL J-FLAP, SACROCOLPOSUSPENSION PROCEDURE, REPAIR OF ENTEROCELE AND ABDOMINAL PERINEAL RESECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLORATORY LAPARATOMY AND REPAIR OF RECURRENT PARASTOMAL HERNIA DUE TO RECURRENT PARASTOMAL HERNIA ON (B)(6) 2009 AND COLOSTOMY DISCONNECTION/REVISION AND FASCIOTOMY AND RELEASE OF PARASTOMAL HERNIA REPAIR DUE TO COLON STRICTURE S/P PARASTOMAL HERNIA REPAIR WITH STRICTURE AT THE HERNIA REPAIR SITE ON (B)(6) 2009. (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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR IMPLANT: POP, SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DYSPAREUNIA, BLEEDING DURING INTERCOURSE AND CAN NO LONGER ENGAGE IN INTERCOURSE, FREQUENT URINARY TRACT INFECTIONS, MRSA (2013), DIARRHEA, CHRONIC VAGINAL AND PELVIC PAIN, URINARY PROBLEMS, HAD TO SELF CATHETERIZE, USED MANY ORAL AND IV ANTIBIOTIC OVER THE YEARS WHICH HAVE COMPROMISED HER IMMUNE SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT FULGURATION OF BLADDER FOREIGN BODIES, URETHROLYSIS ON (B)(6) 2007 DUE TO URINARY RETENTION, URGENCY, FREQUENCY, S/P TEGRESS AND VAGINAL VAULT REPAIR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308839 GYNECARE GYNEMESH* PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. UNK XBP006

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention