BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19068391 · Received April 8, 2024

    Report

    Report Number
    2210968-2024-04053
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    December 12, 2023
    Report Date
    April 8, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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. CITATION: SHARIFIAGHDAS ET AL. AFRICAN JOURNAL OF UROLOGY 2023)/ HTTPS://DOI.ORG/10.1186/S12301-023-00403-0.

    Description of Event or Problem · 0

    TITLE: INVESTIGATING THE CLINICAL OUTCOMES OF BULKING AGENT INJECTION IN COMPARISON WITH MODIFIED GIL-VERNET ANTI-VESICOURETERAL REFLUX SURGERY IN CHILDREN WITH HIGH-GRADE REFLUX (4 OR 5). THE OBJECTIVE OF THIS STUDY IS TO ANALYZE AND COMPARE THE RESULTS OF MODIFIED GIL-VERNET ANTI-REFLUX SURGERY AND BULKING AGENT INJECTION IN CHILDREN WITH UNILATERAL HIGH-GRADE REFLUX. BETWEEN FEBRUARY 2013 TO SEPTEMBER 2019, A TOTAL OF 179 PATIENTS (123 FEMALES AND 56 MALES) WHO UNDERWENT SURGICAL INTERVENTIONS FOR PRIMARY VESICOURETERAL REFLUX (VUR). DYSURIA WAS REPORTED BY 73 (57%) PATIENTS IN THE MODIFIED GIL-VERNET GROUP AND 16 (31%) PATIENTS IN THE DX/HA INJECTION GROUP, AND HEMATURIA WAS FOUNDED IN 57 (47%) PATIENTS IN THE MODIFIED GIL-VERNET GROUP AND 11 (22%) PATIENTS IN THE DX/HA INJECTION GROUP, BOTH OF WHICH WERE STATISTICALLY SIGNIFICANT. THE MEDIAL WALL OF BOTH URETERS WERE SUTURED BY TWO 5¿0 VICRYL SUTURES AND APPROXIMATED TO EACH OTHER IN THE MIDLINE. THE URETERAL ORIFICES WERE CHECKED FOR PROPER EFFLUX OF URINE; THE INCISED TRIGONAL MUCOSA WAS SUTURED LONGITUDINALLY BY SEPARATE 5¿0 VICRYL SUTURES. THE BLADDER AND WOUND WERE CLOSED, SUCTION DRAINAGE, AND A FOLEY CATHETER WAS INSERTED. REPORTED COMPLICATIONS INCLUDED DYSURIA (N=73), FEVER (N=8), PYURIA (N=32), HEMATURIA (N=57), FEBRILE UTI (N=8) AND FLANK PAIN (N=10). IN CONCLUSION, DX/HA INJECTION HAS A SIGNIFICANTLY SHORTER OPERATION TIME, LOWER POSTOPERATIVE ANALGESIC USAGE, AND SHORTER HOSPITAL STAY, MODIFIED GIL-VERNET ANTI-REFLUX SURGERY IS ASSOCIATED WITH SIGNIFICANTLY HIGHER VUR DOWNGRADING AND RESOLUTION RATES THAN DX/HA INJECTION, PARTICULARLY IN THE HIGHER GRADE VUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499366 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention