BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTERIOR PELVIC FLOOR REPAIR S

    MDR report key: 15831723 · Received November 20, 2022

    Report

    Report Number
    2210968-2022-09627
    Event Type
    Injury
    Date Received
    November 20, 2022
    Report Date
    November 20, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    UDI-DI
    10705031062313
    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

    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

    DATE SENT TO THE FDA: 11/22/2022.

    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.

    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 RECURRENT URINE INFECTIONS. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2000 WHICH IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396651 ANTERIOR PELVIC FLOOR REPAIR S MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. 1362894 10705031062313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention