BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 16782059 · Received April 20, 2023

    Report

    Report Number
    2210968-2023-02891
    Event Type
    Injury
    Date Received
    April 20, 2023
    Report Date
    April 20, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 04/20/2023 TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. *IT WAS IDENTIFIED THAT THIS COMPLAINT WAS INADVERTENTLY REPORTED WITH THE INCORRECT PREDICATE 510K DEVICE NUMBER, K013718, INSTEAD OF K071512. D4: UDI: THE FULL UDI IS CURRENTLY NOT AVAILABLE AS THE CATALOG AND/OR LOT NUMBER FOR THE DEVICE INVOLVED WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THRUSH, ABDOMINAL PAIN, BACK PAIN, PROCIDENTIA, RECTOCELE, BLADDER DISCOMFORT, CYSTITIS, DYSPAREUNIA, DYSURIA, FREQUENCY, URINARY STRESS INCONTINENCE, NOCTURIA, VAGINAL BLEEDING, PAINFUL DEFECATION, SUPRA-PUBIC DISCOMFORT, DIARRHEA, VAGINAL DISCHARGE AND CONSTIPATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935618 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention