BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22203375 · Received June 13, 2025

    Report

    Report Number
    2210968-2025-06861
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    October 7, 2024
    Report Date
    July 2, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. CITATION: HTTPS://PUBMED.NCBI.NLM.NIH.GOV/39373101/

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LU L, ZHANG B, TANG L, SHEN J, WANG X, GENG H. COMPARISON OF THE SAFETY AND EFFICACY OF LAPAROSCOPIC SINGLE-INCISION TRIANGULATED UMBILICAL SURGERY PYELOPLASTY WITH TRADITIONAL THREE-HOLE SURGERY IN A PEDIATRIC TERTIARY CENTER. INT J UROL. 2025 JAN;32(1):73-78. DOI: 10.1111/IJU.15598. EPUB 2024 OCT 7. PMID: 39373101. THE AIM OF THIS STUDY IS TO REPORT THE APPLICATION OF LAPAROSCOPIC SINGLE-INCISION TRIANGULATED UMBILICAL SURGERY (SITUS) PYELOPLASTY IN CHILDREN WITH URETEROPELVIC JUNCTION OBSTRUCTION (UPJO) AND COMPARE ITS FEASIBILITY AND EFFICACY WITH TRADITIONAL THREE-HOLE LAPAROSCOPIC PYELOPLASTY. BETWEEN JULY 2018 AND AUGUST 2021, A TOTAL OF THIRTY-TWO PATIENTS FROM SITUS GROUP AND 72 PATIENTS FROM TRADITIONAL GROUP WERE REVIEWED. 62 MALES AND 10 FEMALES WITH A MEDIAN AGE OF 6.0 YEARS (IQR: 4¿7). 5-0 INTERRUPTED SUTURE ( VICRYL; ETHICON) WAS USED TO SUTURE IN THE ANASTOMOTIC SITE AND USED TO CLOSE THE EDGE OF THE ANTERIOR SIDE ANASTOMOSIS. REPORTED COMPLICATIONS ARE: 5-0 INTERRUPTED SUTURE (VICRYL; ETHICON). 7-YEAR-OLD BOY. -POSTOPERATIVE ABDOMINAL PAIN (N=1). TREATMENT: ULTRASONOGRAPHY SHOWED RENAL PELVIC CLOTS BLOCKING ANASTOMOSIS. FAILED CONSERVATIVE TREATMENT LED TO LAPAROSCOPIC EXPLORATION WITH CLOTS REMOVAL, NEPHROSTOMY TUBE INSERTED, WHICH WAS REMOVED 2 WEEKS LATER. 5-0 INTERRUPTED SUTURE (VICRYL; ETHICON). 8-YEAR-OLD GIRL. -COMPLAINED OF PROGRESSIVE SYMPTOMS OF INTERMITTENT FLANK PAIN ACCOMPANIED BY DETERIORATING HYDRONEPHROSIS DURING POSTOPERATIVE FOLLOW-UP (N=1). TREATMENT: A RE-STENTING PROCEDURE WAS PERFORMED AND 6 MONTHS LATER AFTER STENT REMOVAL, THE HYDRONEPHROSIS IMPROVED WITH STABLE RENAL FUNCTION. 5-0 INTERRUPTED SUTURE (VICRYL; ETHICON). -ANASTOMOTIC STENOSIS (N=4). TREATMENT: FOUR NECESSITATED REDO PYELOPLASTY DUE TO FAILED ATTEMPTS TO ALLEVIATE ANASTOMOTIC OBSTRUCTION THROUGH RE-STENTING OR NEPHROSTOMY. IN CONCLUSION, SITUS PYELOPLASTY IS A FEASIBLE AND EFFECTIVE LAPARO-ENDOSCOPIC SINGLE-SITE (LESS) TECHNIQUE FOR PEDIATRIC PATIENTS WITH EXCELLENT COSMETIC RESULTS COMPARABLE TO THE CONVENTIONAL LAPAROSCOPIC PYELOPLASTY. MORE CASES AND LONGER FOLLOW-UP PERIODS ARE NEEDED TO DETERMINE THE EXACT OUTCOMES OF THE MODIFIED LESS TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898987 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention