BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 21311896 · Received February 5, 2025

    Report

    Report Number
    2210968-2025-01380
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    April 29, 2024
    Report Date
    February 5, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL (2024) 35:1145¿1154. HTTPS://DOI.ORG/10.1007/S00192-024-05771-X.

    Description of Event or Problem · 0

    TITLE: A RANDOMISED TRIAL ON THE EFFECTS OF THE ADDITION OF UTEROSACRAL LIGAMENT PLICATION TO PECTOPEXY OPERATION ON ANATOMICAL RESTORATION AND FEMALE SEXUAL FUNCTIONS THE AIM OF THIS STUDY IS TO DETERMINE WHETHER THE ADDITION OF UTEROSACRAL LIGAMENT PLICATION TO PECTOPEXY FOR PELVIC ORGAN PROLAPSE INCREASES ANATOMICAL IMPROVEMENT AND FEMALE SEXUAL FUNCTIONING. BETWEEN AUGUST 2020 TO MARCH 2021, A TOTAL OF 40 PATIENTS WHO UNDERWENT LAPAROSCOPIC PECTOPEXY (LP) AND LAPAROSCOPIC PECTOPEXY WITH UTEROSACRAL LIGAMENT PLICATION (LPUSL) WERE INCLUDED IN THE STUDY. A TOTAL OF 38 PATIENTS, INCLUDING LP (N=20) AND LPUSL (N=18), PARTICIPATED IN THE STUDY. THE STUDY DESIGN IS SHOWN AS A FLOW CHART IN FIG. 1. ALL PATIENTS SIGNED INFORMED CONSENT BEFORE THE OPERATION. THE PATIENTS WHO HAD SYMPTOMATIC APICAL PROLAPSE POP-Q = II WERE INCLUDED IN THE STUDY. WE SPARED THE UTERUS IN ALL CASES BECAUSE THE PATIENTS WANTED TO THIS TO BE PRESERVED, AND ALSO WE BELIEVE THAT UTERINE PROLAPSE IS NOT AN INDICATION FOR HYSTERECTOMY. EXCLUSION CRITERIA WERE ASYMPTOMATIC APICAL PROLAPSE, PREVIOUS OPERATIONS FOR PELVIC ORGAN PROLAPSE, PREVIOUS HYSTERECTOMY AND HAVING A CONTRAINDICATION FOR LAPAROSCOPIC SURGERY. THE STUDY WAS CARRIED OUT ACCORDING TO THE CONSORT STATEMENT. ONCE THE TENSIONING HAS BEEN DONE, THE UTEROSACRAL LIGAMENTS WERE EVALUATED. THE URETER TRACES WERE OBSERVED ON BOTH SIDES. A NON-ABSORBABLE PROLENE SUTURE WAS PUT IN A HELICAL TYPE ON EITHER SIDE OF THE UTEROSACRAL LIGAMENT (FIG. 2C). REPORTED COMPLICATIONS ARE PAIN (N=?), SUDDEN FEELING OF NEEDING TO URINATE (N=2 [3RD POSTOPERATIVE MONTH]; N=2 [12TH POSTOPERATIVE MONTH]), SUDDEN FEELING OF NEEDING TO URINATE WITH INCONTINENCE (N=1 [3RD POSTOPERATIVE MONTH]; N=1 [12TH POSTOPERATIVE MONTH]), FREQUENT URINATION (N=5 [3RD POSTOPERATIVE MONTH]; N=2 [12TH POSTOPERATIVE MONTH]), DIFFICULTY STARTING URINATION (N=1 [3RD POSTOPERATIVE MONTH]), ABNORMAL DISCHARGE OF URINE (N=2 [3RD POSTOPERATIVE MONTH]; N=2 [12TH POSTOPERATIVE MONTH]), NOCTURIA (N=1 [3RD POSTOPERATIVE MONTH]), DYSPAREUNIA (N=6 [3RD POSTOPERATIVE MONTH]; N=2 [12TH POSTOPERATIVE MONTH]), STRESS URINARY INCONTINENCE (N=3 [3RD POSTOPERATIVE MONTH]; N=3 [12TH POSTOPERATIVE MONTH]), DYSURIA (N=2 [3RD POSTOPERATIVE MONTH]), CONSTIPATION (N=4 [3RD POSTOPERATIVE MONTH] AND N=2 [12TH POSTOPERATIVE MONTH]). IN CONCLUSION, BOTH LP AND LPUSL ARE SUCCESSFUL SURGERIES. HOWEVER, ADDING UTEROSACRAL LIGAMENT PLICATION TO THE PECTOPEXY OPERATION IMPROVES THE ANATOMICAL RESTORATION MORE DRASTICALLY THAN LP ALONE. MOREOVER, EITHER LP OR LPUSL HAS IMPROVED THE MAJORITY OF SEXUAL FUNCTION INDICES. HOWEVER, MORE PROSPECTIVE STUDIES WITH LARGER SAMPLE SIZES ARE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160020 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other