BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BRD BLK 15X60CM M3.5

    MDR report key: 13113002 · Received December 29, 2021

    Report

    Report Number
    2210968-2021-13070
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    November 10, 2021
    Report Date
    February 14, 2022
    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: 02/14/2022. 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 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES WERE IDENTIFIED. MFR RETAINED SAMPLE INVESTIGATION SUMMARY: ACTUAL CUSTOMER COMPLAINT SAMPLE OR SAME BATCH REPRESENTATIVE SAMPLE ARE NOT RETURNED. SAME BATCH MANUFACTURER RETAINED SAMPLE EVALUATED FOR [APPEARANCE] AND [TENSILE STRENGTH] PER CURRENT VERSION OF SOP-06-14 AND NO ISSUE FOUND, DETAIL TESTING DATA PLEASE REFERS TO INVESTIGATION PLAN. DHR REVIEWED AND NO ISSUE FOUND. THE ROOT CAUSE OF THIS COMPLAINT CAN¿T BE DETERMINED, THIS COMPLAINT DATA WILL BE KEPT FOR TREND ANALYSIS.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEVICE NOT RETURNED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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: WERE THERE ANY PATIENT CONSEQUENCES? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN APPENDECTOMY SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN. 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
    2011107 SILK BRD BLK 15X60CM M3.5 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. PG3BB

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female