BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHLN BLK 18IN 4-0 S/A P-3 PRM MP

    MDR report key: 15932826 · Received December 7, 2022

    Report

    Report Number
    2210968-2022-10057
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Date of Event
    November 6, 2022
    Report Date
    January 4, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    UDI-DI
    10705031008625
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 1/4/2023. H6 COMPONENT CODE: G07002 NO DEVICE RETURNED. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: QTY TO BE RETURNED : 2 => 0. 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 Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). COMPONENT CODE: G07002. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PROCEDURE DATE: (B)(6) 2022. EVENT DATE: (B)(6) 2022. THE SURGERY WAS AN ORTHOPEDIC SURGERY. ADDITIONAL DESCRIPTION : THE EVENT (THE NEEDLES WERE DETACHED) OCCURRED WHEN AN EPIDERMAL SUTURE WAS PERFORMED FOR THE PATIENT WHO CUT THE PATIENT¿S HAND WITH A CHISEL. QTY TO BE RETURNED : 0, 2. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: PLEASE PROVIDE THE LOT NUMBER: EVENT RELATED TO MW # 2210968-2022-10056. 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 AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE AND THIS HAPPENED TWO TIMES IN A ROW. THE EVENT OCCURRED WHEN AN EPIDERMAL SUTURE WAS PERFORMED FOR THE PATIENT WHO CUT THE PATIENT¿S HAND WITH A CHISEL. THESE WERE NOT CONTROL RELEASE NEEDLES. THE SURGEON HAS USED PRODUCT FOR A LONG TIME AND THIS WAS THE FIRST TIME SOMETHING LIKE THIS HAPPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507993 ETHLN BLK 18IN 4-0 S/A P-3 PRM MP SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE GAR ETHICON INC. 699G 10705031008625

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown