BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18825075 · Received March 4, 2024

    Report

    Report Number
    2210968-2024-02259
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    April 16, 2022
    Report Date
    March 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. CITATIONS : J UROL SURG.9(3):196-202. HTTPS://DOI.ORG/10.4274/JUS.GALENOS.2022.2021.0137.

    Description of Event or Problem · 0

    TITLE : THE ANTERIOR VAGINAL WALL SUSPENSION PROCEDURE: MID-TERM FOLLOW-UP OF A NATIVE TISSUE VAGINAL REPAIR FOR STRESS URINARY INCONTINENCE. THE AIM OF THIS STUDY WAS TO REPORT THE OUTCOMES OF THE ANTERIOR VAGINAL WALL SUSPENSION (AVWS) PROCEDURE FOR STRESS URINARY INCONTINENCE (SUI). BETWEEN 1996 AND 2016, (B)(4) PATIENTS MET THE STUDY CRITERIA. THE MEDIAN FOLLOW-UP WAS 4.2 YEARS, WITH THE MEDIAN NUMBER OF VISITS PER YEAR AT 1.0. THOSE WITH REOPERATION (N=9) HAD SLIGHTLY INCREASED FOLLOW-UP TIME. TYPICALLY, TWO SETS OF #1 PROLENE SUSPENSION SUTURES ARE PLACED BROADLY INTO THE VAGINAL WALL, EXCLUDING THE EPITHELIUM, PROXIMALLY AND DISTALLY ON EACH SIDE AT THE LEVEL OF THE BLADDER NECK AND CYSTOCELE BASE, RESPECTIVELY. THE REPORTED COMPLICATIONS INCLUDED INTRAOPERATIVE BLEEDING (N=3%), SUPRAPUBIC WOUND INFECTION (N=1%), TEMPORARY URINARY RETENTION (N=1%), =6 WEEKS WOUND INFECTION AND PAIN (N=1%). IN CONCLUSION, IN THIS MID-TERM FOLLOW-UP STUDY, THE AVWS PROCEDURE WAS SHOWN TO BE A DURABLE, SIMPLE, AND SAFE NON-MESH REPAIR ALTERNATIVE TO TREAT SUI SECONDARY TO URETHRAL HYPERMOBILITY BY RESTORING THE VAGINAL ANATOMIC SUPPORT TO THE BLADDER NECK AND BLADDER BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193784 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other