BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 22237253 · Received June 17, 2025

    Report

    Report Number
    2210968-2025-06976
    Event Type
    Injury
    Date Received
    June 17, 2025
    Report Date
    June 17, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: INTERNATIONAL JOURNAL OF MEDICAL AND PHARMACEUTICAL RESEARCH, VOL. 6, NO. 2, IJMPR, MAR. 2025, HTTPS://DOI.ORG/10.5281/ZENODO.14986513.

    Description of Event or Problem · 0

    TITLE: VIGILANCE BEYOND THE SCALPEL: THE POST-OP STORY. THIS HOSPITAL-BASED PROSPECTIVE STUDY AIMS TO ANALYZE THE INCIDENCE AND FACTORS CONTRIBUTING TO POSTOPERATIVE COMPLICATIONS IN OBSTETRICS AND GYNECOLOGICAL SURGERIES, WITH A FOCUS ON IDENTIFYING EFFECTIVE PREVENTIVE MEASURES. BETWEEN JANUARY 2023 TO JUNE 2023, A TOTAL OF 4,948 UNDERWENT EMERGENCY LSCS/ LAPAROTOMY (N=2506) AND ELECTIVE PROCEDURE (LSCS/ABDOMINAL HYSTERECTOMY/MYOMECTOMY/RECANALIZATION) (N=2446), WHILE USING MATTRESS SUTURES WITH VICRYL 1-0 (N=3182), SUBCUTICULAR SUTURES WITH VICRYL 1-0 (N=1168), AND SUBCUTICULAR SUTURES WITH MONOCRYL 2-0 (N=598). REPORTED COMPLICATIONS ARE 1-0 VICRYL N=389 SURGICAL SITE COMPLICATIONS/INFECTION. TREATMENT: RE-SUTURING (N=120) 2-0 MONOCRYL N=10 SURGICAL SITE COMPLICATIONS/INFECTION. TREATMENT: NOT REPORTED IN CONCLUSION, SURGICAL SITE INFECTIONS ARE PIVOTAL IN DETERMINING THE ULTIMATE OUTCOMES OF SURGICAL PROCEDURES, AS WELL AS THE MORBIDITY AND MORTALITY OF PATIENTS. THIS STUDY HIGHLIGHTS THE IMPORTANCE OF THOROUGH PREOPERATIVE ASSESSMENTS AND THE USE OF APPROPRIATE SURGICAL TECHNIQUES TO MINIMIZE POSTOPERATIVE COMPLICATIONS. BY EMPHASIZING PATIENT-SPECIFIC FACTORS SUCH AS ANEMIA, DIABETES, AND OBESITY, THE RESEARCH ADVOCATES FOR TAILORED PREVENTIVE MEASURES TO IMPROVE SURGICAL OUTCOMES IN OBSTETRICS AND GYNECOLOGY. COMMONLY IDENTIFIED CHALLENGES INCLUDE OVERCROWDING WITHIN HEALTHCARE FACILITIES, PERFORMING MULTIPLE OPERATIONS SIMULTANEOUSLY, LIMITED CAPACITY FOR POSTOPERATIVE ISOLATION, AND DIFFICULTIES IN STRICTLY ENFORCING VISITOR RESTRICTIONS WITHIN POSTOPERATIVE WARDS. IT IS IMPERATIVE TO CONDUCT COMPREHENSIVE PREOPERATIVE ASSESSMENTS OF PATIENTS, FOCUSING ON THEIR HEMOGLOBIN LEVELS, ACHIEVING OPTIMAL GLYCAEMIC CONTROL, AND EFFECTIVELY MANAGING HYPERTENSION BEFORE SURGICAL PROCEDURES. MOREOVER, PATIENTS SHOULD BE ENCOURAGED TO EMBRACE BEHAVIOURAL MODIFICATIONS, ENCOMPASSING IMPROVEMENTS IN NUTRITIONAL STATUS, PERSONAL HYGIENE PRACTICES, AND EARLY POST-OPERATIVE AMBULATION. PSYCHOLOGICAL EVIDENCE UNDERSCORES THE POTENTIAL BENEFITS OF OFFERING MOTIVATIONAL SUPPORT TO PATIENTS, WHICH CAN CONTRIBUTE TO IMPROVED SURGICAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38661 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other