BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX SYM PDS+ UNI VIO 18IN 1 S/A OS-6

    MDR report key: 13113795 · Received December 29, 2021

    Report

    Report Number
    2210968-2021-13072
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Report Date
    December 29, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031227705
    PMA / PMN Number
    K113004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 01/24/2022. 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 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 WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHEN WAS THE SUTURE BROKE (IN THE PACKAGE, DURING REMOVAL FROM PACKAGE, DURING HANDLING OR DURING USE ON THE PATIENT)? PLEASE SPECIFY : DURING USE ON THE PATIENT. - WHAT IS THE LOT NUMBER? : UNKNOWN. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 2360 G/M.

    Additional Manufacturer Narrative · 0

    (B)(4). VISUAL ANALYSIS OF THE RECEIVED IMAGE DETERMINED THAT A COIL FORMER LABELED WITH PRODUCT CODE SXPP1A201 COULD BE SEEN. THE REPORTED CONDITION COULD NOT BE SEEN IN THE IMAGE. AS PART OF OUR QUALITY PROCESS, MANUFACTURING RECORDS FOR THIS BATCH SERIAL NUMBER WERE REVIEWED AND MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED COMPLAINT AS THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION IS TRACKED FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDS AS PART OF POST-MARKET SURVEILLANCE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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: WHEN WAS THE SUTURE BROKE (IN THE PACKAGE, DURING REMOVAL FROM PACKAGE, DURING HANDLING OR DURING USE ON THE PATIENT)? PLEASE SPECIFY. WHAT IS THE LOT NUMBER? PLEASE DESCRIBE WHERE THE SUTURE BROKE OFF. 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. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME -IRGACARE, ACTIVE INGREDIENT(S)- TRICLOSAN, DOSAGE FORM - SUTURE/SOLID/PARENTERAL, STRENGTH - = 2360 ¿G /M.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011269 SFX SYM PDS+ UNI VIO 18IN 1 S/A OS-6 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. SXPP1A201 10705031227705

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown