BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 24575166 · Received March 11, 2026

    Report

    Report Number
    2210968-2026-02495
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    January 14, 2026
    Report Date
    March 11, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    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. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: JPRAS OPEN. 2026 JAN 14;48:722-734. HTTPS://DOI.ORG/10.1016/J.JPRA.2026.01.002 PMID: 41675564; PMCID: PMC12887721.

    Description of Event or Problem · 0

    TITLE: IMPACT OF INTRAVENOUS TRANEXAMIC ACID ADMINISTRATION ON REDUCTION MAMMOPLASTY OUTCOMES. THE AIM OF THIS STUDY WAS TO ANALYZE THE EFFECT OF IV TXA USE SPECIFICALLY ON REDUCTION MAMMOPLASTY OUTCOMES BY EVALUATING THE LARGEST DATASET UNDERGOING BREAST REDUCTION WITH CONCURRENT INTRAVENOUS (IV) TRANEXAMIC ACID (TXA) ADMINISTRATION. THEY HYPOTHESIZED THAT IV TXA USE WOULD MINIMIZE POSTOPERATIVE COMPLICATIONS FOLLOWING REDUCTION MAMMOPLASTY. AN INSTITUTIONAL REVIEW BOARD (IRB) APPROVED RETROSPECTIVE-DESIGNED STUDY WAS CONDUCTED ON 406 PATIENTS (812 BREASTS) WHO UNDERWENT BILATERAL REDUCTION MAMMOPLASTIES BY SIX SENIOR SURGEONS AT OUR INSTITUTION FROM FEBRUARY 2023 TO AUGUST 2024. OF THE TOTAL 406 PATIENTS (812 BREASTS), 213 (426 BREASTS) RECEIVED IV TXA INTRAOPERATIVELY, WHILE 193 (386 BREASTS) DID NOT. ALL PATIENTS INCLUDED IN THE STUDY SELF-IDENTIFIED AS FEMALE. PATIENTS AVERAGED AN AGE OF 40 PLUS OR MINUS15 YEARS. ALL PATIENTS HAD WISE-PATTERN SKIN EXCISIONS PERFORMED FOR THEIR REDUCTIONS AND WERE SEEN FOR AT LEAST ONE POSTOPERATIVE FOLLOW-UP APPOINTMENT. MOST PATIENTS IN THE TXA COHORT RECEIVED THE ANTIFIBRINOLYTIC DURING ANESTHESIA INDUCTION OR WITHIN 30 MIN OF THE PROCEDURE START TIME. ONLY 6 OF THE 213 PATIENTS WHO RECEIVED TXA WERE ADMINISTERED THE AGENT > 30 MIN AFTER THE PROCEDURE START TIME. AT THE END OF THE PROCEDURE, SOME PATIENTS HAD DRAINS PLACED AT THE SURGEON¿S DISCRETION. FINALLY, INCISIONS WERE CLOSED ACCORDING TO THE SURGEON¿S PREFERENCE, EITHER IN A CONVENTIONAL LAYERED FASHION WITH MONOCRYL OR VICRYL FOR THE DERMAL LAYER AND MONOCRYL FOR SUBCUTICULAR CLOSURE, OR WITH STRATAFIX, ETHIBOND, OR QUILL BARBED SUTURES. DRESSINGS WERE THEN APPLIED. THE AVERAGE FOLLOW-UP OF ALL PATIENTS WAS 141 PLUS OR MINUS 98 DAYS. REPORTED COMPLICATIONS INCLUDE: MONOCRYL. (N=?) SEROMA TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) HEMATOMA. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) DEHISCENCE. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) INFECTION. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) NIPPLE INSENSITIVITY. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) HYPERTROPHIC SCARRING. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) SCAR REVISION. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) FAT NECROSIS. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) READMITTED FOR SURGICAL INTERVENTION TREATMENT: NOT REPORTED IN THE ARTICLE. VICRYL (N=?) SEROMA TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) HEMATOMA TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) DEHISCENCE TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) INFECTION TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) NIPPLE INSENSITIVITY. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) HYPERTROPHIC SCARRING. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) SCAR REVISION. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) FAT NECROSIS. TREATMENT: NOT REPORTED IN THE ARTICLE. (N=?) READMITTED FOR SURGICAL INTERVENTION TREATMENT: NOT REPORTED IN THE ARTICLE. STRATAFIX (N=?) SEROMA TREATMENT: NOT REPORTED IN THE ARTICLE. (N=?) HEMATOMA TREATMENT: NOT REPORTED IN THE ARTICLE. (N=?) DEHISCENCE TREATMENT: NOT REPORTED IN THE ARTICLE. (N=?) INFECTION TREATMENT: NOT REPORTED IN THE ARTICLE. (N=?) NIPPLE INSENSITIVITY TREATMENT: NOT REPORTED IN THE ARTICLE. (N=?) HYPERTROPHIC SCARRING TREATMENT: NOT REPORTED IN THE ARTICLE. (N=?) SCAR REVISION TREATMENT: NOT REPORTED IN THE ARTICLE. (N=?) FAT NECROSIS TREATMENT: NOT REPORTED IN THE ARTICLE. (N=?) READMITTED FOR SURGICAL INTERVENTION TREATMENT: NOT REPORTED IN THE ARTICLE. ETHIBOND (N=?) SEROMA TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) HEMATOMA. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) DEHISCENCE. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) INFECTION. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) NIPPLE INSENSITIVITY. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) HYPERTROPHIC SCARRING. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) SCAR REVISION. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) FAT NECROSIS. TREATMENT: NOT REPORTED IN THE ARTICLE (N=?) READMITTED FOR SURGICAL INTERVENTION TREATMENT: NOT REPORTED IN THE ARTICLE. IN CONCLUSION, THIS STUDY, THE LARGEST TO DATE ON THE USE OF IV TXA DURING REDUCTION MAMMOPLASTY, FOUND THAT TXA USE IS PREDICTIVE OF REDUCED RATES OF WOUND DEHISCENCE AND THE NEED FOR SCAR REVISION AFTER CONTROLLING FOR DEMOGRAPHIC AND PERIOPERATIVE FACTORS. HOWEVER, USING WOUND CLOSURE TECHNIQUES LIKE BARBED SUTURES NEGATES THIS BENEFIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603677 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention