BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 3042776 · Received April 9, 2013

    Report

    Report Number
    2210968-2013-03640
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K063562
    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-03641. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE, CYSTOCELE, HYPERMOBILE URETHROVESICAL ANGLE, AND ATYPICAL SQUAMOUS CELLS OF UNCERTAIN SIGNIFICANCE. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF EXAMINATION UNDER ANESTHESIA AND CYSTOSCOPY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CHRONIC PELVIC AND VAGINAL AREA PAIN AS WELL AS SEVERE INFECTIONS, LEAKAGE, EROSION, BLEEDING, PAINFUL INTERCOURSE AND A VOCAL TREMOR DUE TO A DIFFICULT INTUBATION IN FOUR SURGERIES THE PATIENT UNDERWENT WITHIN A 16 MONTH TIME SPAN. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT ALSO EXPERIENCED PSYCHOLOGICAL AND EMOTIONAL SUFFERING. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2011 PER OPERATIVE REPORT. IT WAS REPORTED THAT PATIENT UNDERWENT COMPLETE REMOVAL OF MESH, URINARY BLADDER RECONSTRUCTION AND IMPLANT OF MUSCLE TISSUE RING ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY DUE TO STRESS URINARY INCONTINENCE AND CYSTOCELE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2011 AND (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY INCONTINENCE AND VAGINAL NECROSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146406 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3436412

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention