BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3083735 · Received April 29, 2013

    Report

    Report Number
    2210968-2013-04671
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AND MESH WAS IMPLANTED CONCURRENTLY WITH TRANSVAGINAL HYSTERECTOMY DUE TO PELVIC ORGAN PROLAPSE. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINE RETENTION AND URINARY FREQUENCY. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 08/09/2016.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY LEAKAGE, SQUIRTING URINE, SPOTTING, PASSED SOME BLOOD CLOTS, URINARY INFECTION, NOCTURIA, AND VAGINAL ATROPHY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED INTO THE PATIENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY LEAKAGE, SQUIRTING URINE, SPOTTING, PASSED SOME BLOOD CLOTS, URINARY INFECTION, NOCTURIA, AND VAGINAL ATROPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185402 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3076448

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention