BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3042772 · Received April 9, 2013

    Report

    Report Number
    2210968-2013-03592
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 2210968-2013-03585. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR IMPLANT: SUI VAGINAL VAULT PROLAPSE, CYSTOCELE AND ANTERIOR /POSTERIOR FASCIAL DEFECT. CONCURRENT PROCEDURES: DIAGNOSTIC CYSTOSCOPY, SACROSPINOUS SUSPENSION AND ANTERIOR COLPORRHAPHY. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED ANTERIOR MESH EXPOSURE, VAGINAL BLEEDING, VAGINAL PRESSURE, VAGINAL TEARING, VAGINAL SCARRING, GRANULATION TISSUE, VAGINAL DISCHARGE, VAGINAL PRESSURE, WORSENING INCONTINENCE, RECURRENT UTI¿S, HYPERTENSION SECONDARY TO PAIN, MESH EROSION AND LOWER BACK PAIN. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2006 AND (B)(6) 2007 BY IMPLANTING SURGEON. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A CHOLECYSTECTOMY ON (B)(6) 2012 DUE TO CHRONIC CHOLECYSTITIS AND CHOLELITHIASIS. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE 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
    145816 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 2897783

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention