BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3053409 · Received April 11, 2013

    Report

    Report Number
    2210968-2013-03734
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 21, 2013
    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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT PELVIC ORGAN PROLAPSE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT AFTER INSERTION OF THE MESH THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFECTION, DYSPAREUNIA, VAGINAL SCARRING AND URINARY, BOWEL AND NEUROMUSCULAR PROBLEMS. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-03735. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008, AND A MESH WAS IMPLANTED DUE TO PELVIC PAIN, PELVIC MASS, SUI, INTRINSIC SPHINCTER DEFICIENCY, VENTRAL HERNIA, INCISIONAL HERNIA, AND HTN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-03735. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY, URINARY URGENCY, AND MUSCLE SPASM. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2008 CONCURRENTLY WITH A TRANSABDOMINAL EXPLORATORY LAPAROTOMY, REVISION OF SACRAL COLPOPEXY, EXPLORATION OF SACRUM, CYSTOURETHROSCOPY, VENTRAL HERNIORRHAPHY, AND INCISION HERNIORRHAPHY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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. IT WAS REPORTED THAT PATIENT UNDERWENT EXPLORATORY LAPAROTOMY EXTENSIVE ENTEROLYSIS SYNTHETIC SLING CYSTOSCOPY WITH SUPRAPUBIC CATHETER PLACEMENT (B)(6) 2008, DUE TO BOWEL DYSFUNCTION AND SUI. IT WAS REPORTED THAT PATIENT UNDERWENT INJECTION OF BOTOX INTO THE PUBORECTALIS MUSCLE, EXPLORATORY LAPAROSCOPY WITH LYSIS OF ADHESIONS ON (B)(6) 2011 AND (B)(6) 2011, DUE TO CHRONIC RECTAL PAIN, PELVIC PAIN, AND CONSTIPATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY, URINARY URGENCY, AND MUSCLE SPASM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154226 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA AEE127

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention