BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE SUTURE 18IN (45CM) 5-0 BLU

    MDR report key: 24608309 · Received March 16, 2026

    Report

    Report Number
    2210968-2026-02649
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    January 1, 2026
    Report Date
    March 16, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). DATE SENT TO THE FDA: 4/15/2026. 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: H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED

    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. 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 WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY? ¿ MORE THAN 24 DID THE EVENT OCCUR DURING ONE OR MULTIPLE PATIENT PROCEDURES? - MULTIPLE WHAT IS THE TOTAL NUMBER OF PROCEDURES? ¿ APPROX. 15 HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY IN EACH PROCEDURE? -2 HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, COULD YOU PLEASE PROVIDE THE CORRESPONDING REFERENCE NUMBER(S)? -NO WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS RESULTING FROM THE PROLONGED SURGERY TIME? ¿ NOT REPORTED. HOW LONG, IN MINUTES, DID THE SURGERY PROLONG? ¿ NOT REPORTED WHICH TISSUE WAS BEING SUTURED WHEN THE EVENT OCCURRED? ¿ CARTILAGES & SOFT TISSUES DURING RHINOPLASTY. WAS ADDITIONAL DISSECTION REQUIRED IN OTHER ORGANS/TISSUES OTHER THAN THE TARGET TISSUE? NOT REPORTED. WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? NOT REPORTED. PLEASE 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) ¿ NOT SURE WHO SHOULD IT BE. PLEASE PROVIDE WITH THE SHIPPING STATUS AND THE SHIPMENT TRACKING NUMBER ¿ AS PER PREVIOUS SOPS IT SHOULD BE COLLECTED AND SHIPPED BY DISTRIBUTOR, (B)(4). ADDITIONAL H11: WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 2-5, ACTION TAKEN WHEN EVENT OCCURRED? ANOTHER AMPULE OF SUTURE OPENED, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. "D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, ENT/PLASTIC DOCTOR, WHO PERFORMS RHINOPLASTIES & WHO HAS BEEN USING ETHICON SUTURES FOR MORE THAN 30 YEARS AND PARTICULARLY PROLENE 5-0, HAS COMPLAINED THAT HE STARTED TO CONSTANTLY FACE ISSUES WITH THE NEEDLES: SPECIFICALLY WITH PROLENE 5-0 CUTTING NEEDLES W8872T START TO BEND AND BREAK EASILY AND THAT IMPACTS THE PROCEDURE: TIME, QUALITY IF STITCHING ETC. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206616 PROLENE SUTURE 18IN (45CM) 5-0 BLU SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 10769C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown