BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24253796 · Received February 3, 2026

    Report

    Report Number
    2210968-2026-01290
    Event Type
    Injury
    Date Received
    February 3, 2026
    Date of Event
    June 6, 2025
    Report Date
    February 3, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: J CLIN MED. 2025 JUN 6;14(12):4019. HTTPS://DOI.ORG/10.3390/JCM14124019. PMID: 40565765; PMCID: PMC12194653.

    Description of Event or Problem · 0

    TITLE: OESOPHAGEAL PERFORATION SURGICAL TREATMENT: WHAT AFFECTS THE OUTCOME? A MULTICENTER EXPERIENCE. OESOPHAGEAL PERFORATION (OP) IS A LIFE-THREATENING CONDITION REQUIRING PROMPT DIAGNOSIS AND TREATMENT. MORTALITY IS INFLUENCED BY SEVERAL FACTORS, SUCH AS AETIOLOGY, DEFECT LOCATION, COMORBIDITIES, AGE, AND DELAYS IN TREATMENT. THIS STUDY REVIEWS PATIENTS WITH OP UNDERGOING SURGERY, ANALYZING MORTALITY RISKS AND THE IMPACT OF TIMING ON SURGICAL OUTCOMES. BETWEEN JANUARY 2014 AND DECEMBER 2023, A TOTAL OF 45 PATIENTS WERE EVALUATED: 31MALE (68.88%) AND 14 FEMALE (31.12%). SURGICAL MANAGEMENT INCLUDED PRIMARY REPAIR OF THE PERFORATION, DEBRIDEMENT, DRAINAGE OF THE PLEURAL CAVITY AND/OR CERVICAL AREA, AND, IN SEVERE CASES, OESOPHAGEAL RESECTION WITH OR WITHOUT GASTRECTOMY. FOR OP CAUSED BY FOREIGN BODIES, TRAUMA, IATROGENIC INJURIES, OR BOERHAAVE¿S SYNDROME WITHIN 24 H, OESOPHAGOTOMY WITH FOREIGN BODY REMOVAL AND DIRECT REPAIR (>2CM WITHOUT NECROSIS) WAS PERFORMED VIA THORACOTOMY OR CERVICOTOMY. AFTER ISOLATING THE OESOPHAGUS AND REMOVING NECROTIC TISSUE, THE MUCOSAL PLANE WAS SUTURED USING 4/0 VICRYL INTERRUPTED STITCHES, AND THE MUSCULAR PLANE WAS SUTURED WITH 3/0 VICRYL SUTURES. THE MEDIAN AGE OF 66.00 PLUS OR MINUS 17.75. REPORTED COMPLICATIONS INCLUDE: VICRYL SUTURE (3/0 AND 4/0; ETHICON), FEVER (N=17), TREATMENT: NOT REPORTED, FISTULA (N=7), TREATMENT: NOT REPORTED, SURGICAL WOUND INFECTION (N=2), TREATMENT: NOT REPORTED, OESOPHAGEAL SUB-STENOSIS (N=2), TREATMENT: TREATED WITH ENDOSCOPIC DILATATION, LEAK (N=2), TREATMENT: TREATED BY CERVICOTOMY AND PACKING, FAILURE OF INITIAL REPAIR (N=4), TREATMENT: UNDERWENT BIPOLAR EXCLUSION. IN CONCLUSION, OP IS A LIFE-THREATENING CONDITION WITH HIGH MORTALITY. PRIMARY REPAIR IS THE PREFERRED TREATMENT. OESOPHAGECTOMY AND GASTRECTOMY ARE RESERVED FOR EXTENSIVE LESIONS. MUSCLE FLAPS CAN REINFORCE SUTURES IN CERVICAL AND THORACIC PERFORATIONS. MORTALITY IS MAINLY INFLUENCED BY THE SEVERITY OF THE PATIENT¿S CLINICAL PICTURE AND COMORBIDITIES, RATHER THAN BY TIME AND TYPE OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310132 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention