BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHLN BLK 18IN 3-0 S/A SC-20

    MDR report key: 17277364 · Received July 7, 2023

    Report

    Report Number
    2210968-2023-04883
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    January 1, 2023
    Report Date
    August 2, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, THEY JUST CHANGED FROM SUTURE WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? N/A. PATIENT STATUS/ OUTCOME / CONSEQUENCES. NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO. IS THE PATIENT PART OF A CLINICAL STUDY? NO. WHEN WAS THE SUTURE BROKE (IN THE PACKAGE, DURING REMOVAL FROM PACKAGE, DURING HANDLING PRIOR TO USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE SPECIFY DEVICE RETURN STATUS. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER: PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: ANSWERS: DURING HANDLING PRIOR TO USE ON PATIENT AND DURING USE ON THE PATIENT - AS THERE WERE SEVERAL CASES IN DIFFERENT DAYS, CUSTOMER WAS INFORMED BY THEIR OR STAFF ABOUT THIS ISSUES DAYS AFTER THEY HAD HAPPENED, THIS IS WHY THEY DIDN'T KEEP THE MATERIAL, JUST SENT A PICTURE WITH THE LOT NUMBER OF THE SUTURE. THE PERSON WHO PROVIDED THIS INFORMATION IS MR. (B)(6), FROM PURCHASE DEPARTMENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640922 ETHLN BLK 18IN 3-0 S/A SC-20 SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. AT8541

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown