BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE UNKNOWN

    MDR report key: 19622705 · Received June 27, 2024

    Report

    Report Number
    2210968-2024-06667
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Date of Event
    January 1, 2024
    Report Date
    June 27, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. THE SINGLE COMPLAINT WAS REPORTED WITH POSSIBLE MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL PATIENT EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. PLEASE PROVIDE PRODUCT CODE AND LOT NUMBER. PLEASE CLARIFY IF THIS HAPPEN MORE THAN ONE TIME IN THIS SINGLE PROCEDURE STATUS OF PRODUCT RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE FELL OFF THE SUTURE. THE CASE WAS COMPLETED WITH THE SAME BOX. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807934 SUTURE UNKNOWN SUTURE, ABSORBABLE GAK ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown