BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 15797390 · Received November 15, 2022

    Report

    Report Number
    2210968-2022-09441
    Event Type
    Injury
    Date Received
    November 15, 2022
    Date of Event
    December 24, 2021
    Report Date
    November 16, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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 2210968-2022-09442. CITATION: J. CLIN. MED. 2022, 11, 136. HTTPS://DOI.ORG/10.3390/JCM11010136.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 11/16/2022. 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.

    Description of Event or Problem · 0

    TITLE: EVALUATION OF FUNCTIONAL OUTCOMES AND QUALITY OF LIFE IN ELDERLY PATIENTS (>75 Y.O. UNDERGOING MINIMALLY INVASIVE RADICAL CYSTECTOMY WITH SINGLE STOMA URETEROCUTANEOSTOMY VS. BRICKER INTRACORPOREAL ILEAL CONDUIT URINARY DIVERSION. THIS STUDY AIMS TO COMPARE COMPLICATIONS AND QOL IN PATIENTS AGED > 75 Y.O., WHO UNDERWENT MINIMALLY INVASIVE (MI) RADICAL CYSTECTOMY (RC) WITH BRICKER INTRACORPOREAL URINARY DERIVATION AND SINGLE STOMA URETEROCUTANEOSTOMY. FROM MAY 2016 TO MARCH 2020, A RETROSPECTIVE ANALYSIS OF 78 MEDICAL RECORDS OF PATIENTS WHO UNDERWENT MINIINVASIVE RADICAL CYSTECTOMY WITH INTRACORPOREAL NON-CONTINENT HETEROTOPIC NEOBLADDER (ILEAL CONDUIT AS DESCRIBED BY BRICKER) OR SINGLE STOMA URETEROCUTANEOSTOMY, WAS CONDUCTED. ACCORDING TO THE URINARY DIVERSION PERFORMED, PATIENTS WERE DIVIDED INTO TWO GROUPS: GROUP A, CONSISTING OF 37 PATIENTS (25 MALES AND 12 FEMALES, MEAN AGE WAS 77.2 YEARS OLD), WHO UNDERWENT A BRICKER ILEAL CONDUIT; GROUP B CONSISTED OF 41 PATIENTS (28 MALES AND 13 FEMALES, MEAN AGE WAS 77.2 WAS 82.4 YEARS OLD), WHO UNDERWENT SINGLE-STOMAL URETEROSTOMY (AS DOUBLE-BARRELED URETEROCUTANEOSTOMY). A 45 MM ENDO GIA AUTOMATIC STAPLER WAS USED TO DISSECT THE BOWEL PROXIMALLY AND DISTALLY AND A 3-0 VICRYL RAPID SUTURE WAS USED FOR THE STENTS THAT WERE FIXED TO THE UTERUS FOR THE BRICKER ILEAL CONDUIT DIVERSION. A VICRYL RAPID 3-0 SUTURE WERE USED TO FIX THE UTERUS TO THE ABDOMINAL FASCIA DURING SINGLE STOMA URETEROCUTANEOSTOMY. MEAN FOLLOW-UP WAS 14.4 MONTHS (RANGE 8¿16 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: GROUP A: BRICKER ILEAL CONDUIT DIVERSION, (N=?) CLAVIEN-DINDO GRADE I¿II, (N=?) CLAVIEN-DINDO GRADE III-IV, GROUP B: SINGLE STOMA URETEROCUTANEOSTOMY, (N=?) UROPERITONEUM, (N=?) PARALYTIC ILEUS, (N=?) CLAVIEN-DINDO GRADE III-IV. IN CONCLUSION, IN ELDERLY PATIENTS THIS STUDY SHOWS THAT, FOR BLADDER CANCER, THE CHOICE OF MINIMALLY INVASIVE RADICAL CYSTECTOMY WITH SINGLE STOMA URETEROCUTANEOSTOMY COULD REPRESENT A VALID ALTERNATIVE TO HETEROTOPIC URINARY DIVERSION WITH BRICKER ILEAL CONDUIT, WHICH IS THE MORE COMMON ALTERNATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149156 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention