BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON BLUE 1.0M 45CM W/NDL

    MDR report key: 21263704 · Received January 29, 2025

    Report

    Report Number
    2210968-2025-01035
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 6, 2025
    Report Date
    January 29, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    UDI-DI
    10705031125476
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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: VERBAL RESPONSE FROM HCP FOR PCF1 ACCORDING TO SALES REP. DID THE 24 DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY. IF DIFFERENT, PLEASE CONFIRM HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY ON THIS SINGLE EVENT? [ANS: AROUND 8-10 PIECES FROM THIS BATCH DEMONSTRATED THE ALLEGED DEFICIENCY.] H3 PHOTO INVESTIGATION SUMMARY: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS AN OPEN BOX LABELED AS W1616T AND A CLOSED SINGLE BARRIER FOLDER. THE IMAGE IS NOT CLEAR TO DETERMINE THE FAILURE MODE OR THE REPORTED CONDITION. BASED ON THE PHOTO REVIEW, THE EVENT DESCRIBE IS NOT CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE DEVICE WAS NOT RETURNED OUR EVALUATION IS LIMITED. WE VALUE THE OPPORTUNITY TO FULLY ANALYZE THE DEVICE UPON ITS RETURN. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 8/6/2025. CORRECTED INFORMATION: D3, H6 INVESTIGATIONAL CODES. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, DENTIST REFLECTED THAT THE SUTURE IS BROKEN EASILY DURING THE DENTAL OPERATION, ESPECIALLY NEAR TO THE NEEDLE AND IN THE MIDDLE OF THE SUTURE. THE QUALITY IS NOT AS WELL PERFORMED AS USUAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995105 ETHILON BLUE 1.0M 45CM W/NDL SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. REBEPX 10705031125476

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown