BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX SYM PDS+ UNI VIO 18IN 0 S/A CT-1

    MDR report key: 14886349 · Received July 1, 2022

    Report

    Report Number
    2210968-2022-05063
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    May 8, 2022
    Report Date
    July 27, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031219342
    PMA / PMN Number
    K113004
    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). EVALUATION: THIS IS AN ANALYSIS OF A PHOTO SUBMITTED FOR REVIEW. PRODUCT SAMPLE NOT RECEIVED. DURING THE VISUAL ANALYSIS THE FOLLOWING WAS OBSERVED: THE TWO PHOTOS SHOW A WINDING FORMER AND A SUTURE SECTION WITH THE PRODUCT CODE. IMAGE IS NOT CLEAR TO DETERMINE FAILURE MODE. BASED ON THE PHOTO REVIEW, THE EVENT DESCRIBE IS CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE INSTRUMENT WAS NOT RETURNED OUR EVALUATION IS LIMITED. WE VALUE THE OPPORTUNITY TO FULLY ANALYZE THE INSTRUMENT UPON ITS RETURN. AS PART OF QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO PRODUCT 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). TRADE NAME - IRGACARE® ACTIVE INGREDIENT(S) ¿ TRICLOSAN DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL STRENGTH ¿ = 2360 ¿G/M ALL OTHERS 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 7/27/2022. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT TISSUE WAS BEING APPROXIMATED/ SUTURED? ALL ANSWERS ABOVE ARE UNOBTAINABLE. ONCE THERE IS ANY UPDATE, WE WILL UPDATE THE INFORMATION. PROCEDURE NAME? TRADE NAME - IRGACARE® ACTIVE INGREDIENT(S) ¿ TRICLOSAN DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL STRENGTH ¿ = 2360 G/M ALL OTHERS.

    Description of Event or Problem · 0

    BREAKAGE SUTURE. IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO REPORTED PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009295 SFX SYM PDS+ UNI VIO 18IN 0 S/A CT-1 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. SXPP1A401 QDMDPH 10705031219342

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown