BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE

    MDR report key: 24663339 · Received March 23, 2026

    Report

    Report Number
    2210968-2026-02957
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    February 1, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031019324
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 3/23/2026 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 INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: 1. WHAT IS THE ACCOUNT NAME/IMPACTED HOSPITAL? IT WAS LEFT BLANK IN THE COMPLAINT. ANS: LOH GUAN LYE SPECIALIST HOSPITAL 2. WERE THERE ANY ADVERSE EVENTS (I.E. INFECTION/COMPLICATION ETC), PATIENT CONSEQUENCES OR HARM TO THE PATIENT? ANS: NO ADVERSE EVENT, THE ISSUE IS SOLVED BY CHANGING A NEW SUTURE 3. WAS THE SURGERY COMPLETED SUCCESSFULLY? ANS: YES 4. DID THE ISSUE RESULT IN ADDITIONAL MEDICAL/SURGICAL INTERVENTION (I.E. REVISION SURGERY ETC) FOR THE PATIENT? ANS: NO 5. IS THE LOT NUMBER FOR THE IMPACTED PRODUCT AVAILABLE? I. IF YES, PLEASE PROVIDE THE LOT NUMBER. ANS: NO II. IF NO, PLEASE CONFIRM IF YOU HAVE REACHED OUT TO THE HCP TO OBTAIN THE BATCH DETAILS. ANS: NO INFO ON THIS 1. IF IT BECOMES AVAILABLE IN THE FUTURE, PLEASE PROVIDE LOT NUMBER. - WILL UPDATE THE LOT NUMBER IF AVAILABLE 2. PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ). - MATRON KHOR ¿ LOH GUAN LYE SPECIALIST 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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/22/2026 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 INFORMATION: D4, G1, H4, H6 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: 1. IF IT BECOMES AVAILABLE IN THE FUTURE, PLEASE PROVIDE LOT NUMBER. ANS: "BATCH: UBBELX".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING CABG PROCEDURE, USED SUTURE AND IT SNAPPED WHEN DOING ANASTOMOSIS, INTRA OPERATION. THE ISSUE IS THEN RESOLVED BY DISCARDED THE SNAPPED SUTURE AND OPEN ANOTHER SUTURE TO REPLACE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732631 PROLENE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. UBBELX 10705031019324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown