BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL UD 18IN 5-0 S/A PS-2 PRM MP

    MDR report key: 21011118 · Received December 24, 2024

    Report

    Report Number
    2210968-2024-13941
    Event Type
    Malfunction
    Date Received
    December 24, 2024
    Date of Event
    November 26, 2024
    Report Date
    December 24, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K964072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION PROVIDED: BROKE 3'XS. ALL 3 SUTURE CAME FROM ONE BOX LOT NUMBER ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ¿ WHAT WAS THE NAME OF THE PROCEDURE? REVISION OF SCALP SCAR ¿ WHAT WAS THE PROCEDURE DATE? (B)(6) 24. ¿ WHAT IS CURRENT CONDITION OF THE PATIENT? STABLE. ¿ ARE THE DAMAGED SUTURES AVAILABLE TO BE RETURNED FOR EVALUATION? NO. NO PRODUCT IS AVAILABLE FOR RETURN. 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.

    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: H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT AN REVISION OF SCALP SCAR PROCEDURE ON AN (B)(6) 2024 AND SUTURE WAS USED. WHILE SUTURING DURING A CASE THE SUTURE BROKE , THERE WAS NO LOSS SUFFERED TO THE PATIENT. IT WAS NOT SURE WHAT MEASURES WHERE TAKEN TO CORRECT THE PROBLEM DURING THE PROCEDURE. PATIENT IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966092 MCRYL UD 18IN 5-0 S/A PS-2 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. SJMJUC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown