BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 13005345 · Received December 14, 2021

    Report

    Report Number
    2210968-2021-12597
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 3, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). DATE SENT TO THE FDA: 01/11/2022 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. ADDITIONAL INFORMATION: H6 THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: PLEASE PROVIDE THE PRODUCT CODE AND LOT NUMBER?¿¿ACCORDING TO THE FEEDBACK OF THE SALES REPRESENTATIVE, ALL THE ABOVE ANSWERS ARE UNKNOWN. HOW MANY SUTURES BROKE INTRA-OP? DID ONE SUTURE BREAK 3 TIMES? WERE THERE ANY ADVERSE PATIENT CONSEQUENCES OR ANY ISSUES DUE TO THE BROKEN BLOOD VESSEL OR THIS EVENT?

    Additional Manufacturer Narrative · 0

    (B)(4). 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. 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 THE PRODUCT CODE AND LOT NUMBER? HOW MANY SUTURES BROKE INTRA-OP? DID ONE SUTURE BREAK 3 TIMES? WERE THERE ANY ADVERSE PATIENT CONSEQUENCES OR ANY ISSUES DUE TO THE BROKEN BLOOD VESSEL OR THIS EVENT? WAS THE PROCEDURE COMPLETED SUCCESSFULLY? EVENTS REPORTED IN 2210968-2021-12596 AND 2210968-2021-12598.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTERIOVENOUS FISTULA REPAIR FOR RENAL DIALYSIS AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN LIGATING THE VESSEL. THE BLOOD VESSEL WAS ALSO BROKEN WHEN DEALING WITH THE SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896295 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male