BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILK 3/0 45CM 26MM CT CVD

    MDR report key: 18603619 · Received January 29, 2024

    Report

    Report Number
    2210968-2024-00756
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    January 16, 2024
    Report Date
    February 8, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    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). 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 WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: RECEIVED INFORMATION AS FOLLOWING FROM SALES REP VIA PHONE TODAY. AFTER INVESTIGATION, THE PATIENT'S GENDER AND AGE WERE UNKNOWN. IN (B)(6) 2024 (THE SPECIFIC DATE WAS UNKNOWN), THE PATIENT UNDERWENT HEMODIALYSIS IN HOSPITAL (THE SPECIFIC PATIENT'S DIAGNOSIS AND SURGICAL OPERATION WERE UNKNOWN). THE SURGEON USED W2511 TO PERFORM THE SKIN AND SUBCUTANEOUS TISSUE SEWING IN THE WAY OF INTERRUPTED SUTURING AND FIX THE CATHETER (THE SPECIFIC CATHETER PRODUCT INFORMATION AND CATHETERIZATION SITE WERE UNKNOWN), AND THE INTRAOPERATIVE OPERATION WAS SMOOTH. 2~3 DAYS AFTER THE SURGERY (JANUARY 16, 2024), THE SUTURE BROKE AT THE SEWING SITE (THE SPECIFIC SUTURE BREAKAGE SITE WAS UNKNOWN), AND THE DOCTOR PERFORMED RE-SUTURING. THE PATIENT RECOVERED WELL CURRENTLY AND NO FURTHER ADVERSE EVENTS WERE REPORTED. INVESTIGATION SUMMARY 2 UNOPENED PACK (TJ404/W2511) WAS RETURNED TO ETHICON FOR EVALUATION. THE RETURN SAMPLE HAS BEEN EVALUATED BY APPEARANCE AND KNOT PULL TENSILE STRENGTH TEST. 2 RETURN SAMPLE WERE MANUFACTURED BY ETHICON AND THERE IS NO APPEARANCE ISSUE FOUND. THE KNOT PULL TEST RESULTS WERE MET THE SPECIFICATION. DHR REVIEWED AND NO ISSUE FOUND. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

    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. 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 PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. DATE AND NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WERE THERE ANY PATIENT STRESS FACTORS THAT PRECIPITATED THE EVENT OF SUTURE BREAKAGE POST OP? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED TO SEW THE SKIN IN ORDER TO FIX THE CATHETER UNDER SKIN TISSUE. ABOUT 2 DAYS AFTER THE SURGERY, THE SUTURE WAS FOUND BROKE. THE SUTURE WAS REMOVED AND RE-SEWING WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250871 MERSILK 3/0 45CM 26MM CT CVD SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. TJ404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention