BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 23137050 · Received September 24, 2025

    Report

    Report Number
    2210968-2025-10942
    Event Type
    Injury
    Date Received
    September 24, 2025
    Date of Event
    December 27, 2024
    Report Date
    September 24, 2025
    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

    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: INT UROL NEPHROL. 2025 MAY;57(5):1465-1471. HTTPS://DOI.ORG/10.1007/S11255-024-04345-6 EPUB 2024 DEC 27. PMID: 39725832.

    Description of Event or Problem · 0

    TITLE: MOBILE APP COMMUNICATION TO PREVENT ER VISITS POST-CIRCUMCISION: A PROSPECTIVE OBSERVATIONAL STUDY. THIS STUDY AIMS TO ASSESS THE IMPACT OF A MOBILE PHONE APPLICATION FACILITATING REAL-TIME VISUAL AND VERBAL COMMUNICATION ON REDUCING EMERGENCY-ROOM ADMISSIONS FOLLOWING CIRCUMCISION. BETWEEN APRIL 2024 AND JUNE 2024, A TOTAL OF 162 PATIENTS AGED 0¿3 YEARS AND 6¿13 YEARS WHO UNDERWENT CIRCUMCISION USING VICRYL RAPID, WERE INCLUDED IN THE STUDY. INDIVIDUAL PHONE NUMBERS HAD BEEN PROVIDED BY PHYSICIANS TO 75 OF THEM, INSTRUCTING THEM TO SEND ANY POST-SURGICAL QUESTIONS VIA THE MOBILE APPLICATION USING IMAGES. THIS GROUP WAS DESIGNATED AS THE ¿COMMUNICATING GROUP¿ OR ¿GROUP 1¿. THE OTHER 87 PATIENTS WERE REMINDED OF PRE-PROCEDURE INSTRUCTIONS UPON POSTDISCHARGE FOLLOW-UP AND INFORMED THAT THEY COULD CONSULT THE EMERGENCY DEPARTMENT OR OUTPATIENT CLINIC IF NEEDED, AND THEY WERE IDENTIFIED AS THE ¿NON-COMMUNICATING GROUP¿ OR ¿GROUP 2¿. REPORTED COMPLICATIONS ARE: VICRYL RAPID, N=3 WOUND INFECTION TREATMENT: EMERGENCY VISIT, N=6 NON-HEALING WOUND TREATMENT: EMERGENCY VISIT, N=5 SWELLING AND INFLAMMATION TREATMENT: EMERGENCY VISIT, N=6 BLEEDING TREATMENT: CAUTERIZATION (N=1), N=6 PAIN AND DISCOMFORT TREATMENT: EMERGENCY VISIT, N=3 ISSUES WITH MICTURITION TREATMENT: EMERGENCY VISIT, IN CONCLUSION, OUR STUDY¿S FINDINGS DEMONSTRATE THAT VERBAL AND VISUAL COMMUNICATION FOLLOWING CIRCUMCISION THROUGH A MOBILE PHONE APPLICATION CAN EFFECTIVELY ALLEVIATE THE PHYSICIAN¿S WORKLOAD, REDUCE THE FREQUENCY OF UNNECESSARY EMERGENCY VISITS, LOWER ANXIETY LEVELS BY INCREASING FAMILY AWARENESS, AND STREAMLINE THE POST-OPERATIVE PROCESS. FUTURE RESEARCH SHOULD FOCUS ON RANDOMIZED CONTROLLED TRIALS TO FURTHER VALIDATE THESE FINDINGS. IN ADDITION, ASSESSING ANXIETY LEVELS AND USING STANDARDIZED TOOLS TO EVALUATE COMMUNICATION QUALITY AND LONG-TERM OUTCOMES WOULD OFFER DEEPER INSIGHTS INTO THE EFFECTIVENESS, SUSTAINABILITY, AND POTENTIAL BROADER APPLICATION OF MOBILE COMMUNICATION IN POST-OPERATIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851170 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention