BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2983379 · Received February 28, 2013

    Report

    Report Number
    2210968-2013-01912
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 2210968-2013-01916. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2007 AND (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT UNDERWENT A D&C AND LAPAROSCOPIC LYSIS OF FILMY ADHESIONS ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED, DUE TO UTERINE PROLAPSE, CYSTOCELE, RECTOCELE, AND STRESS URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT UTERINE PROLAPSE AND STRESS URINARY INCONTINENCE. THE PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2011. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-01916. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 06/30/2016.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2008 BY DR. (B)(6) DUE TO EXTRUDED MESH.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 06/20/2017. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY INCONTINENCE, CYSTOCELE, INCOMPLETE BLADDER EMPTYING AND SPOTTING.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CHRONIC URINARY TRACT INFECTION, URINARY FREQUENCY AND BURNING SENSATION.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT VAGINAL MESH EXCISION AND CYSTOSCOPY ON (B)(6)2017 BY DR. (B)(6).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, AND VAGINAL SCARRING. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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
    87468 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON INC NA 2987236

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention