BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 22160208 · Received June 6, 2025

    Report

    Report Number
    2210968-2025-06451
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    September 20, 2024
    Report Date
    June 27, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    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. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. 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: SURG. TECH. DEV. 2024, 13, 313¿324. DOI: HTTPS://DOI.ORG/10.3390/STD13030024.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    TITLE: THE USE OF CRYOPRESERVED UMBILICAL TISSUE AS AN ADJUNCTIVE THERAPY IN IMMEDIATE BREAST-RECONSTRUCTION PATIENTS AT HIGH RISK FOR WOUND-HEALING COMPLICATIONS: CASE-REPORT SERIES AND PRELIMINARY RESULTS. THE AIM OF THIS STUDY IS TO INTRODUCE THE USE OF CRYOPRESERVED UMBILICAL TISSUE (VCUT) AS AN ADJUNCT THERAPY FOR HIGH-RISK-WOUND-HEALING IMMEDIATE BREAST RECONSTRUCTION (IBR) PATIENTS. BETWEEN 2022 TO 2023, A TOTAL OF 7 PATIENTS. THE AVERAGE AGE WAS 52 YEARS (RANGE, 41¿75), AND ALL PATIENTS WERE FEMALE. AVERAGE BMI WAS 31.7 KG/M2 (RANGE, 22.1¿38.5). OF THE SEVEN PATIENTS INCLUDED IN THIS SERIES, FIVE PATIENTS RECEIVED VCUT PLACEMENT IMMEDIATELY DURING THE PRIMARY RECONSTRUCTION (CASES 1¿5), WHILE TWO PATIENTS RECEIVED VCUT IN DELAYED/SUBSEQUENT RECONSTRUCTIVE PROCEDURES (CASES 6 AND 7). ONE-TO-TWO 3 CM × 6 CM PIECES OF VCUT WERE LONGITUDINALLY SPLIT, TACKED TO THE DERMIS OF THE DE-EPITHELIALIZED LOWER SKIN FLAP USING 3-0 MONOCRYL SUTURES, AND THE UPPER SKIN FLAPS WERE DRAPED OVER THEM. REPORTED COMPLICATIONS ARE: 3-0 MONOCRYL SUTURES (ETHICON). CASE 5 41-YEAR-OLD, FEMALE, WHITE (N=1). -TISSUE EXPANDER INFECTION. TREATMENT: TREATED WITH IV ANTIBIOTICS AND TISSUE-EXPANDER REMOVAL. IN CONCLUSION, AS UNDERGOING IBR LEADS TO IMPROVED MENTAL HEALTH AND SUPERIOR AESTHETIC OUTCOMES, EFFORTS TO EXPAND CURRENT INDICATIONS FOR SAFE IBR TO TRADITIONALLY POORER RECONSTRUCTIVE CANDIDATES ARE IMPERATIVE. THE RESULTS OF THIS CASE SERIES DEMONSTRATE VCUT AS A PROMISING NOVEL ADJUNCTIVE TOOL IN THE RECONSTRUCTIVE SURGEONS¿ ARMAMENTARIUM IN MANAGING THE LESS IDEAL RECONSTRUCTIVE BREAST CANDIDATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550865 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention