BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERSILK 4/0 75CM16MM CR CUT

    MDR report key: 13064289 · Received December 22, 2021

    Report

    Report Number
    2210968-2021-12909
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    September 5, 2021
    Report Date
    December 22, 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: 01/18/2022. 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: PLEASE CLARIFY IF THERE WERE ANY ADVERSE PATIENT CONSEQUENCES DUE TO THIS EVENT? IF YES, PLEASE EXPLAIN IN DETAIL----ACCORDING TO THE FEEDBACK OF THE SALES, IT IS UNKNOWN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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 CLARIFY IF THERE WERE ANY ADVERSE PATIENT CONSEQUENCES DUE TO THIS EVENT? IF YES, PLEASE EXPLAIN IN DETAIL. 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 ORAL SURGERY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING IN EXTRACTION OF IMPACTED TEETH. AFTER EXAMINATION, IT WAS SUSPECTED THAT THE NEEDLE WAS BENT BY CLAMPING THE NEEDLE, RESULTING IN BRITTLE NEEDLE. 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
    1958231 MERSILK 4/0 75CM16MM CR CUT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. MD209

    Patients

    Seq Age Sex Outcome Treatment
    1 Female