BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18793426 · Received February 27, 2024

    Report

    Report Number
    2210968-2024-02037
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    July 26, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. AN ATTEMPT HAS BEEN 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. RELATED EVENTS CAPTURED VIA 2210968-2024-02036, 2210968-2024-02037, 2210968-2024-02038, 2210968-2024-02039, 2210968-2024-02040. CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL (2022): HTTPS://DOI.ORG/10.1007/S00192-022-05283-6.

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC AND ROBOT-ASSISTED SUTURE VERSUS MESH HYSTEROPEXY: A RETROSPECTIVE COMPARISON THE AIM OF THIS RETROSPECTIVE COHORT STUDY IS TO COMPARE THE OUTCOMES OF LAPAROSCOPIC AND ROBOT-ASSISTED SUTURE-BASED HYSTEROPEXY (SUTURE) VERSUS SACRAL HYSTEROPEXY USING MESH (MESH) FOR BOTHERSOME UTERINE PROLAPSE. BETWEEN SEPTEMBER 2010 AND OCTOBER 2018, A TOTAL OF 228 WOMEN WHO UNDERWENT RE-SUSPENSION OF THE UTERUS USING UTEROSACRAL LIGAMENTS (SUTURE N=97) OR A ¿U-SHAPED¿ MESH FROM THE SACRAL PROMONTORY (MESH, N=132). IN SUTURE, A BIDIRECTIONAL BARBED ABSORBABLE SUTURE (BIDIRECTIONAL STRATAFIX; ETHICON, USA) AND 0 PROLENE SUTURE (ETHICON, USA) WERE USED. IN MESHH, MESHES USED INCLUDED PHYSIOMESH (ETHICON, USA), ULTRAPRO (ETHICON, USA), RESTORELLE (COLOPLAST, DENMARK) AND TIMESH (PFM, GERMANY), WHICH WERE HAND-CUT U-SHAPED AND IS SECURED WITH DELAYED ABSORBABLE SUTURES (2-0 PDS) ON THE ANTERIOR CERVIX. ONE-YEAR FOLLOW-UP DATA WERE AVAILABLE FOR 191 WOMEN (MESHH N=120 (MEAN AGE WAS 54.05 YEARS); SUTURE N=71 (MEAN AGE WAS 48.5 YEARS). REPORTED COMPLICATIONS INCLUDE THE FOLLOWING PER GROUP: SUTURE. (N=?) RECURRENT UTERINE PROLAPSE. (N=2) REPORTED NO CHANGE AND (N=6) REPORTED WORSENING OF SYMPTOMS RELATED TO PROLAPSE ON PGI-I (N=5.6%) STRESS INCONTINENCE. (N=4.2%) OVERACTIVE BLADDER. (N=4.2%) DYSPAREUNIA. (N=5.6%) PELVIC PAIN. (N=2.8%) DEFECATORY DIFFICULTY. (N=1.4%) DYSFUNCTIONAL UTERINE BLEEDING. (N=1) RECURRENCE OF SYMPTOMS 3 MONTHS INTO THE PREGNANCY. MESH (N=?) RECURRENT UTERINE PROLAPSE. (N=4) REPORTED NO CHANGE AND (N=1) REPORTED WORSENING OF SYMPTOMS RELATED TO PROLAPSE ON PGI-I. (N=2) POSTERIOR WALL HAEMATOMA. (N=1) PELVIC PAIN DUE TO ADHESIONS AND A HYDROSALPINX (MESH USED WAS PHYSIOMESH). (N=1) FAECAL LOADING AT 4 WEEKS. (N=5) VOIDING DYSFUNCTION. (N=5.8%) STRESS INCONTINENCE. (N=4.2%) OVERACTIVE BLADDER. (N=5.8%) DYSPAREUNIA. (N=3.3%) PELVIC PAIN. (N=0.8%) DEFECATORY DIFFICULTY. (N=1.7%) DYSFUNCTIONAL UTERINE BLEEDING. (N=2) VAGINAL GRANULOMA. (N=1) OSTEITIS PUBIS. IN CONCLUSION, LAPAROSCOPIC AND ROBOT-ASSISTED LAPAROSCOPIC SUTURE HYSTEROPEXY AND MESH SACRAL HYSTEROPEXY PROVIDE WOMEN WITH MINIMALLY INVASIVE, DURABLE SURGICAL OPTIONS FOR UTERINE PRESERVATION. ¿COMPOSITE SUCCESS¿ WAS SIMILAR IN THE TWO GROUPS, BUT MESHH PROVIDED BETTER UTERINE SUPPORT THAN SUTURE. HOWEVER, SUTURE GIVES WOMEN AN EFFECTIVE MESH-FREE OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931536 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention