BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3140349 · Received May 31, 2013

    Report

    Report Number
    2210968-2013-06331
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    June 18, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED DUE TO CYSTOCELE AND URINARY STRESS INCONTINENCE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL /VULVAR BURNING, URINARY FREQUENCY, LEAKAGE AND URINARY RETENTION. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DIFFICULTY WITH URINARY INCONTINENCE, SENSATION OF INCOMPLETE BLADDER EMPTYING WITH SLOW AND WEAK STREAM, VOIDS AT NIGHT, SENSATION OF BLADDER FULLNESS, AND PERSISTENT SUPRAPUBIC PRESSURE AND DISCOMFORT.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT EXPERIENCED PELVIC PAIN, INCOMPLETE BLADDER EMPTYING, VAGINAL EXTRUSION OF MESH AND A CYSTOCELE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION OF EXPOSED MESH AND REVISION OF VAGINAL GRAFT ON (B)(6) 2007. THE PATIENT UNDERWENT PARAVAGINAL REPAIR, CYSTOSCOPY, COLPOPEXY AND EXCISION OF VAGINAL MESH ON (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE ON (B)(6) 2006 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, DYSPAREUNIA, BLEEDING, URINARY AND BOWEL PROBLEMS, AND EROSION OF HER INTERNAL TISSUES. SHE WAS DIAGNOSED WITH EXPOSED MESH IN THE VAGINA AND UNDERWENT A PARTIAL DISSECTION OF THE EXPOSED MESH ON (B)(6) 2007. IN 2010, THE PATIENT WAS TREATED FOR CONSTANT AND SHARP SUPRAPUBIC PAIN, WEAK URINARY STREAM, AND INCOMPLETE BLADDER EMPTYING. AFTER EXAMINATION, THERE WAS EVIDENCE OF VAGINAL MESH EXTRUSION AND A REMOVAL OF THE EXPOSED MESH WAS RECOMMENDED. ON (B)(6) 2010, SHE UNDERWENT HER SECOND PARTIAL DISSECTION OF MESH. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL /VULVAR BURNING, URINARY FREQUENCY, LEAKAGE AND URINARY RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DIFFICULTY WITH URINARY INCONTINENCE, SENSATION OF INCOMPLETE BLADDER EMPTYING WITH SLOW AND WEAK STREAM, VOIDS AT NIGHT, SENSATION OF BLADDER FULLNESS, AND PERSISTENT SUPRAPUBIC PRESSURE AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242266 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 1353048

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention