BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19025161 · Received April 2, 2024

    Report

    Report Number
    2210968-2024-03763
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    November 26, 2022
    Report Date
    April 2, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED (VICRYL SUTURE) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS: STENOSIS, FALSE PASSAGE, LEAKAGE, STOMAL PROLAPSE, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON PRODUCTS (VICRYL SUTURE) HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATION: JOURNAL OF PEDIATRIC SURGERY. HTTPS://DOI.ORG/10.1016/J.JPEDSURG.2022.11.016 0022-3468/ 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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: MEDIUM-TERM OUTCOMES OF ANTEGRADE CONTINENT ENEMA (ACE): CAIRO UNIVERSITY SPECIALIZED PEDIATRIC HOSPITAL (CUSPH) EXPERIENCE. THE AIM OF THIS STUDY IS TO ASSESS THE MEDIUM-TERM OUTCOMES OF ACE IN CHILDREN WITH FECAL INCONTINENCE (FI). ELIGIBLE CHILDREN WERE RECRUITED FROM THE COLORECTAL CLINIC BETWEEN DECEMBER 2016 AND JANUARY 2020 AND WERE FOLLOWED PROSPECTIVELY FOR 2-6 YEARS. 24 CHILDREN AGED 6-12 YEARS (MEAN AGE 8.17 ± 1.95), INCLUDING 18 MALES (75%) AND 6 FEMALES (25% WERE STUDIED). CASES INCLUDED ANORECTAL MALFORMATIONS (45.83%)., HIRSCHSPRUNG DISEASE (25%), NEURAL TUBE DEFECTS (16.66%), SACROCOCCYGEAL TERATOMA (4.16%), AND INTRACTABLE PSEUDOINCONTINENCE (8.33%). DURING THE SURGERY, THE STOMA IS MATURED WITH 4/0 VICRYL SUTURES TO FASCIA THEN TO SKIN. A TEN FR FOLEY CATHETER IS INSERTED UNDER VISION. THE BALLOON OF THE CATHETER IS INFLATED BY 3 ML SALINE. THE CATHETER IS TESTED FOR FLUSHING AND ASPIRATION USING A 50 ML SYRINGE. REPORTED COMPLICATION: STENOSIS (N-4). FALSE PASSAGE (N-1). LEAKAGE(N-1). STOMAL PROLAPSE(N-3). CONCLUSION: ACE IS AN EFFECTIVE METHOD TO KEEP THE CHILD WITH FI CLEAN, MORE SOCIALLY ACTIVE, AND WITH A BETTER QOL AND FII IN THE MEDIUM-TERM. THE REPORTED COMPLICATIONS WERE STENOSIS, FALSE PASSAGE, AND LEAKAGE. ACE MUCOSA PROLAPSE IS A NOVEL COMPLICATION PICKED UP ON MEDIUM-TERM FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019201 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention