BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 15796516 · Received November 15, 2022

    Report

    Report Number
    2210968-2022-09440
    Event Type
    Injury
    Date Received
    November 15, 2022
    Date of Event
    July 9, 2021
    Report Date
    November 15, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PC: (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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-09439. CITATION: CLIN. EXP. OBSTET. GYNECOL. 2021 VOL. 48(4), 935-941. P

    Description of Event or Problem · 0

    TITLE: ANATOMICAL AND CLINICAL OUTCOMES OF VAGINALLY ASSISTED LAPAROSCOPIC LATERAL SUSPENSION IN COMPARISON WITH LAPAROSCOPIC LATERAL SUSPENSION. IN THIS RETROSPECTIVE STUDY, WE AIMED TO DESCRIBE THESURGICAL PROCEDURE FOR VAGINALLY ASSISTED LAPAROSCOPIC LATERAL SUSPENSION (VALLS) AND TO COMPARE ITS ANATOMICAL AND CLINICAL OUTCOMES WITH LAPAROSCOPIC LATERAL SUSPENSION (LLS). THE SURGICAL OUTCOMES OF 26 WOMEN WITH ADVANCED-STAGE PELVIC ORGAN PROLAPSE (POP) UNDERGOING VALLS AND 35 WOMEN WITH ADVANCED-STAGE POP UNDERGOING LLS WERE RETROSPECTIVELY ANALYSED AND COMPARED BETWEEN FEBRUARY 2013 AND MARCH 2020. A NO.2-0 PROLENE® (MONOFILAMENT POLYPROPYLENE SUTURE; ETHICON, SOMERVILLE, NJ, USA) SUTURE, AN ABSORBABLE NO.0 VICRYL RAPIDE (POLYGLACTIN 910; ETHICON, SOMERVILLE, NJ, USA) SUTURE AND A NO. 2-0 ABSORBABLE VICRYL RAPIDE SUTURE WAS USED DURING THE SURGERY. THE MEDIAN POST-OPERATIVE FOLLOW-UP DURATION WAS 22 (13¿30) MONTHS IN THE VALLS GROUP AND 32 (14¿69) MONTHS IN THE LLS GROUP. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: VALLS GROUP. RECURRENCE: - APICAL COMPARTMENT (N=1). - ANTERIOR COMPARTMENT (N=1). - POSTERIOR COMPARTMENT (N=1). REPEAT SURGERY (RETROPUBIC SLING) FOR SUI (N=4). LLS GROUP. RECURRENCE: - APICAL COMPARTMENT (N=3). - ANTERIOR COMPARTMENT (N=5). - POSTERIOR COMPARTMENT (N=2). REPEAT SURGERY (RETROPUBIC SLING) FOR SUI (N=5). IN CONCLUSION, VALLS APPEARS TO BE A RELIABLE AND EFFICIENT MODIFIED METHOD FOR WOMEN WITH POP SCHEDULED FOR LLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2705440 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention