BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE

    MDR report key: 25055658 · Received May 1, 2026

    Report

    Report Number
    2210968-2026-04723
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031019348
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. D4: FULL UDI CURRENTLY UNAVAILABLE SINCE THE EXACT LOT OF THE SUSPECTED DEVICE CANNOT BE DETERMINED. ADDITIONAL INFORMATION: D4, H4 - THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING THE REPORTED POSSIBLE BATCH NUMBERS: BATCH 104MDG MFG DATE: UNKNOWN, EXP DATE: UNKNOWN. BATCH 107PH0 MFG DATE: 4/10/2025, EXP DATE: 3/31/2030. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. 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. FOR THE INTRA-OP EVENT OF MULTIPLE 7-0 PROLENE SUTURES ¿BROKE, PULLED APART, FELL APART AND DISINTEGRATED¿. PLEASE CONFIRM THE QUANTITY FOR EACH LOT NUMBER. LOT 107PH0 ¿ 3 DEVICES. IS THIS CORRECT? IF THIS IS NOT CORRECT, PLEASE CLARIFY. LOT 104MDG ¿ 1 DEVICE. IS THIS CURRENT? IF THIS IS NOT CORRECT, PLEASE CLARIFY. THE INITIAL EVENT INFORMATION STATED THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE EVENT - PATIENT HAD EXTRA BLEEDING THAT NEEDED TO BE MONITORED PLEASE CLARIFY: IS THE EXTRA BLEEDING THAT HAD TO BE MONITORED REFER THE BLEEDING EXPERIENCED INTRA-OP WHERE ADDITIONAL SUTURES WERE REQUIRED OR THE POST-OP BLEEDING? WHAT WERE THE RESULTS OF MONITORING THE BLEEDING? WAS ANY ADDITIONAL INTERVENTION REQUIRED FOR THE BLEEDING? FOR EXAMPLE, A BLOOD TRANSFUSION. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WERE ANY CONCOMITANT PROCEDURES PERFORMED? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? FOR THE ORIGINAL INTENDED CLOSURE, HOW WERE ALL LAYERS CLOSED? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? WERE SLEEVES OR BOLSTERS USED ON INSTRUMENTS TO HANDLE THE SUTURES? WHAT WAS THE VOLUME OF BLOOD LOSS THAT OCCURRED DURING THE INITIAL PROCEDURE? WHAT WAS THE VOLUME OF BLOOD LOSS THAT OCCURRED POST-OP? WHEN DID THE BLEEDING OCCUR POST-OP (NUMBERS OF HOURS/DAYS)? WHAT WAS THE BLEEDING SOURCE AND TRIGGERING EVENT? WAS THERE ANY SUTURE DEFICIENCY WITH THE SUTURE THAT WAS IN PLACE WHEN THE POST-OP BLEEDING OCCURRED? HOW WAS THE BLEEDING TREATED? PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WAS THE PATIENT ON ANTI-COAGULANTS PRIOR TO SURGERY? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? SURGEON¿S NAME? WILL ANY ACTUAL SAMPLES OR REPRESENTATIVE SAMPLES BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. ADDITIONAL INFORMATION: OTHER PRODUCTS UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT: SURGICEL POWDER, VISTASEAL, SURGIFLO, VICRYL SUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CV CABG SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. POST-OP, THE PATIENT SHOWED BLEEDING AND THE DOCTOR OVER SEWED THE SUTURE WITH A DIFFERENT SIZE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504548 PROLENE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 10705031019348

    Patients

    Seq Age Sex Outcome Treatment
    1