BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFXSYM PDS+ UNI VIO 18IN 2-0 SA SH

    MDR report key: 22523199 · Received July 16, 2025

    Report

    Report Number
    2210968-2025-08218
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Report Date
    August 15, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031227729
    PMA / PMN Number
    K141776
    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED ( RE-OPERATION; PRODUCT REMOVAL: RE-CLOSURE: MEDICATION)? IF SO, PLEASE SPECIFY. WAS A PRESCRIPTION FOR STEROIDS OR ANTIBIOTICS ISSUED FOR THE PATIENT'S RECOVERY? IF YES, PLEASE PROVIDE THE MEDICATION NAME, ROUTE, AND DOSE. PLEASE CLARIFY: ARE THERE ANY PLANS IN PLACE TO REMOVE THE SUTURE/S IN THE FUTURE? IF SO, COULD YOU PLEASE PROVIDE THE SCHEDULED DATE FOR THE REMOVAL? WILL THE SUTURE/S BE REMOVED IN A ROUTINE POST-OP PROCEDURE? WILL THE SUTURE/S BE REMOVED IN A REOPERATION PROCEDURE? WILL THE SUTURE/S BE TRIMMED IN THE PHYSICIAN¿S OFFICE? IF RE-SUTURING/RE-CLOSURE WILL BE PERFORMED: WAS REOPERATION NECESSARY TO REMOVE THE SUTURES AND RE-CLOSE THE WOUND? WHAT IS THE CURRENT PATIENT STATUS? RECEIVED INFORMATION AS FOLLOWING FROM REPORTER VIA PHONE TODAY. PLEASE REFER TO THE EVENT DESCRIPTION, OTHER INFORMATION REQUESTED IS UNKNOWN. 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 REVIEWED.: THE INVOLVED SUTURE CODE SHOULD BE SXPP1A409 WITH LOT RDMETR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT DID THREAD LIFTING SURGERY, AND FEEDBACK POSTOPERATIVE FACIAL SWELLING, UNEVEN AND SUSPECT THE BARB WAS NOT HANGED INTO TISSUE. AND SUSPECT THE SUTURE IS SXPP1A409 OR SXPP1A101. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543622 SFXSYM PDS+ UNI VIO 18IN 2-0 SA SH SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. RDMETR 10705031227729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown