BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 2801634 · Received October 23, 2012

    Report

    Report Number
    2210968-2012-06800
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ETHICON INC
    Product Code
    OTP
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DYSPAREUNIA. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-06798. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY PROBLEMS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT INTERSTIM BATTERY AD LEAD REMOVAL AND HYDRODISTENTION WITH ICFS INSTALLATION FOR COMPLAINT OF CHRONIC INTERSTITIAL CYSTITIS ON (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 04/28/2016.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY, HYDRODISTENTION AND INSERTION OF ICFS DUE TO INTERSTITIAL CYSTITIS ON (B)(6) 2006 BY DR. (B)(6). OPERATIVE INDICATIONS STATES THAT THE PATIENT HAS FREQUENCY, URGENCY, PELVIC PAIN, AND PUF SCORE OF 29. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT IMPLANTABLE PULSE GENERATOR (IPG) AND PROGRAMMING ON (B)(6) 2007 DUE TO INTRACTABLE FREQUENCY, URGENCY, AND URINARY RETENTION BY DR. (B)(6). IT WAS ALSO REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY WITH HYDRODISTENTION AND ICFS ON (B)(6) 2008, (B)(6) 2009, (B)(6) 2010 (BLADDER BIOPSY WITH FULGURATION), (B)(6) 2010 DUE TO CHRONIC INTERSTITIAL CYSTITIS BY DRS. (B)(6).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INTERSTITIAL CYSTITIS, AND URGE INCONTINENCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY, HYDRODISTENTION AND INSERTION OF ICFS DUE TO INTERSTITIAL CYSTITIS ON (B)(6) 2006 BY DR. (B)(6). OPERATIVE INDICATIONS STATES THAT THE PATIENT HAS FREQUENCY, URGENCY, PELVIC PAIN, AND PUF SCORE OF 29. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT IMPLANTABLE PULSE GENERATOR (IPG) AND PROGRAMMING ON (B)(6) 2007 DUE TO INTRACTABLE FREQUENCY, URGENCY, AND URINARY RETENTION BY DR. (B)(6). IT WAS ALSO REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY WITH HYDRODISTENTION AND ICFS ON (B)(6) 2008, (B)(6) 2009, (B)(6) 2010 (BLADDER BIOPSY WITH FULGURATION), (B)(6) 2010 DUE TO CHRONIC INTERSTITIAL CYSTITIS BY DRS. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MESH EROSION, PAIN, INFECTION, DYSPAREUNIA AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL, POLYMERIC OTP ETHICON INC NA 3483012

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention