BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24223896 · Received January 30, 2026

    Report

    Report Number
    2210968-2026-01142
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    November 10, 2025
    Report Date
    January 30, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    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: PLAST RECONSTR SURG GLOB OPEN. 2025 NOV 10;13(11):E7196. HTTPS://DOI.ORG/10.1097/GOX.0000000000007196 PMID: 41220875; PMCID: PMC12599751.

    Description of Event or Problem · 0

    TITLE: COMPARATIVE ANALYSIS OF AESTHETIC ABDOMINOPLASTY VERSUS SIMPLE ABDOMINAL CLOSURE IN DEEP INFERIOR EPIGASTRIC PERFORATOR FLAP BREAST RECONSTRUCTION. THE AIM OF THIS STUDY TO DETERMINE WHETHER PERFORMING COSMETIC TREATMENT ON THE DONOR SITE OF THE ABDOMEN HAS ANY SIGNIFICANCE IN IMPROVING AESTHETICS FOR PATIENTS WHO UNDERWENT RECONSTRUCTION WITH A DIEP FLAP. THIS STUDY INCLUDED A TOTAL OF 46 PATIENTS, FOR A TOTAL OF 54 FLAPS, DIVIDED INTO 2 GROUPS: GROUP 1 (STANDARD CLOSURE) WITH 21 PATIENTS AND GROUP 2 (AESTHETIC CLOSURE) WITH 25 PATIENTS. GROUP 1 (STANDARD CLOSURE): PATIENTS IN THIS GROUP RECEIVED CONTINUOUS FASCIAL CLOSURE WITH VICRYL 0 SUTURES. QUILTING SUTURES WERE PLACED IN AN INTERRUPTED FASHION USING VICRYL 0. CLOSED SUCTION DRAINS WERE PLACED IN ALL PATIENTS. THE SUPERFICIAL FASCIA WAS APPROXIMATED WITH INTERRUPTED VICRYL 2-0 SUTURES, AND THE SKIN WAS CLOSED USING A SINGLE-LAYER INTRADERMAL MONOCRYL 3-0 SUTURE. GROUP 2 (AESTHETIC CLOSURE): PATIENTS IN THIS GROUP RECEIVED CONTINUOUS FASCIAL CLOSURE WITH BARBED STRATAFIX SUTURES. IN BOTH GROUPS, A PROPHYLACTIC PROLENE MESH WAS PLACED BENEATH THE ANTERIOR RECTUS FASCIA TO PREVENT POST OPERATIVE BULGING OR HERNIA. THIS MESH WAS NOT USED AS A BRIDGING MATERIAL AND WAS NOT EXTERNALLY VISIBLE. THESE PRODUCTS WERE USED ON THE PATIENTS INVOLVED AND CANNOT BE COMPLETELY RULED OUT AS A COMPLAINT. REPORTED COMPLICATIONS INCLUDE: VICRYL SUTURES (0, 2-0; ETHICON). SEROMAS (N=2). SKIN NECROSIS (N=4). HEMATOMA (N=2.4%). TREATMENT: NOT REPORTED. STRATAFIX SUTURES (ETHICON). SEROMAS (N=1). SKIN NECROSIS (N=2). TREATMENT: NOT REPORTED. MONOCRYL 3-0 SUTURE (ETHICON). SEROMAS (N=2). SKIN NECROSIS (N=4). HEMATOMA (N=2.4%). TREATMENT: NOT REPORTED. IN CONCLUSION, THIS STUDY COMPARED STANDARD AND AESTHETIC CLOSURE TECHNIQUES IN DIEP FLAP BREAST RECONSTRUCTION, FOCUSING ON AESTHETIC OUTCOMES AND COMPLICATIONS. AESTHETIC CLOSURE, WHICH INCLUDED BARBED SUTURES AND OPTIONAL LIPOSUCTION, LED TO A MODEST BUT NONSIGNIFICANT INCREASE IN PATIENT SATISFACTION. DESPITE A LONGER OPERATIVE TIME, HOSPITAL STAY AND COMPLICATION RATES WERE COMPARABLE BETWEEN GROUPS, INDICATING THAT THE APPROACH IS SAFE FOR SELECTED PATIENTS WITHOUT INCREASING THE HEALTHCARE BURDEN. HOWEVER, THE LACK OF STATISTICALLY SIGNIFICANT DIFFERENCES SUGGESTS THAT ROUTINE USE MAY NOT BE WARRANTED. AESTHETIC CLOSURE MAY OFFER BENEFITS ONLY IN SPECIFIC PATIENT POPULATIONS, SUCH AS THOSE WITH LOWER BMI OR LOCALIZED ADIPOSITY. LARGER, PROSPECTIVE STUDIES WITH LONG TERM FOLLOW-UP AND PATIENT-REPORTED OUTCOMES ARE NEEDED TO VALIDATE THESE FINDINGS AND REFINE PATIENT SELECTION CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284789 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other