BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 17950254 · Received October 17, 2023

    Report

    Report Number
    2210968-2023-07897
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    January 16, 2023
    Report Date
    October 18, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. 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: WEB ADDRESS : HTTPS://DOI.ORG/10.1016/J.JPEDSURG.2023.01.043.

    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. ADDITIONAL INFORMATION: CONCOMITANT PRODUCT - PLASTIBELL DEVICE.

    Description of Event or Problem · 0

    TITLE: OUTCOME ASSESSMENT OF OFFICE PLASTIBELL CIRCUMCISION IN INFANTS UTILIZING INTERACTIVE ELECTRONIC HEALTH RECORD. THIS STUDY AIMED TO ASSESS THE OUTCOMES OF OFFICE-BASED CIRCUMCISION PERFORMED USING PLASTIBELL DEVICES IN INFANTS, UTILIZING THE MYCHART INTERACTIVE ELECTRONIC HEALTH RECORD SYSTEM TO MONITOR THE PROGRESS AND IDENTIFY POTENTIAL COMPLICATIONS. THIS PROSPECTIVE COHORT STUDY MONITORED INFANTS UNDERGOING PLASTIBELL CIRCUMCISION IN A PEDIATRIC SURGERY OFFICE. THIS STUDY WAS CONDUCTED FROM MARCH 2021 TO APRIL 2022. CRITERIA FOR OFFICE CIRCUMCISION INCLUDED INFANTS YOUNGER THAN 3 MONTHS OLD WITHOUT A KNOWN BLEEDING DISORDER OR ALLERGY TO LIDOCAINE. A TOTAL OF 234 INFANTS UNDERWENT OFFICE BASED PLASTIBELL CIRCUMCISION USING SILK (ETHICON). THE REPORTED COMPLICATION INCLUDED PAIN (N=1) TREATMENT: MANUAL RING REMOVAL, BLEEDING (N=2) TREATMENT: TOPICAL PACKING, AND FIBRINOUS ADHESION (N=3) TREATMENT: MANUAL RING REMOVAL. IN CONCLUSION, THE INTERACTIVE UTILIZATION OF IEHR COMMUNICATION IN THE POST-CIRCUMCISION PERIOD IDENTIFIED PROXIMAL BELL MIGRATION AND BELL TRAPPING, ALLOWED EARLIER INTERVENTION AND REDUCED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96463 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other PLASTIBELL DEVICE