BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 16539795 · Received March 14, 2023

    Report

    Report Number
    2210968-2023-01681
    Event Type
    Injury
    Date Received
    March 14, 2023
    Date of Event
    December 1, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: JOURNAL OF CHINESE PHYSICIANS (DECEMBER 2018); VOL. 20 (12):1833-1834. D01: 10.3760/CMA. 2 ISSE. 1003-1372.2218.12.019.

    Description of Event or Problem · 0

    TITLE: CLINICAL OBSERVATION OF PROLIFT PELVIC FLOOR RECONSTRUCTION IN THE TREATMENT OF PELVIC ORGAN PROLAPSE. THE AIM OF THIS STUDY IS TO ANALYZE THE EFFICACY OF PROLIFT PELVIC RECONSTRUCTION ON PELVIC ORGAN PROLAPSE AND ITS EFFECT ON QUALITY OF LIFE AND PELVIC MUSCLE STRENGTH. BETWEEN APRIL 2014 AND FEBRUARY 2017, TOTAL OF 63 PATIENTS WITH PELVIC PROLAPSE WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO CONTROL AND OBSERVATION GROUPS ON A RANDOM-NUMBER BASIS. IN THE CONTROL GROUP CONSISTED OF 22 PATIENTS [AGED 52 TO 73 YEARS (60.43 ± 7.11); WEIGHT INDEX OF 2. 25 (22.59 ± 1.59 KG/M2)] WHILE 34 PATIENTS [AGES 92 - 74 (65.52 ± 7.17); BMI OF 21 - 29 (22.51 ± 1.62) K/M2] IN THE OBSERVATION GROUP. THE OBSERVATION GROUP WERE TREATED WITH PROLIFT PELVIC FLOOR RECONSTRUCTION. REPORTED COMPLICATIONS INCLUDE SEXUAL INTERCOURSE PAIN (N=5), VAGINAL ANTERIOR MESH EXPOSURE (N=2), AND RECURRENCE AFTER SURGERY (N=1). IN CONCLUSION, PROLIFT PELVIC FLOOR RECONSTRUCTION IS A SIMPLE, LESS INVASIVE AND SAFE PROCEDURE FOR THE CORRECTION OF PELVIC ORGAN PROLAPSE. IT CAN PROMOTE THR RECOVERY OF PELVIC FLOOR MUSCLE FUNCTION AND THE CURATIVE EFFECT IS BETTER THAN THE TRADITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935068 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other