BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19001287 · Received March 28, 2024

    Report

    Report Number
    2210968-2024-03614
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    July 19, 2023
    Report Date
    March 28, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS 109 (2023) 108512 HTTPS://DOI.ORG/10.1016/J.IJSCR.2023.108512.

    Description of Event or Problem · 0

    TITLE: PEDIATRIC PATIENT WITH A COMPLEX ABDOMINAL WALL DEFECT RECONSTRUCTED WITH SANDWICH OMENTAL FLAP. A CASE REPORT A CASE OF A 9-YEAR-OLD MALE PATIENT WITH RECURRENT FIBROMYXOID SARCOMA OF THE ABDOMINAL WALL. PRIOR HISTORY REVEALED THAT THE PATIENT HAD DEVELOPED THIS ANTERIOR ABDOMINAL SWELLING (INITIALLY PAINLESS, THEN DEVELOPED A RAPID GROWTH) AT THE AGE OF 3 YEARS. THE LESION WAS EXCISED ENTIRELY IN OTHER INSTITUTION, AND NO CHEMOTHERAPY WAS GIVEN. ONE YEAR LATER, THE ANTERIOR ABDOMINAL MASS STARTED TO RECUR AT THE SITE OF RESECTION. THE HISTOPATHOLOGICAL RESULTS CONFIRMED THE DIAGNOSIS OF A LOW-GRADE FIBROMYXOID SARCOMA. SUBSEQUENTLY, THE PATIENT CONTINUED TO FOLLOW UP WITH THE ONCOLOGY TEAM. NEOADJUVANT TREATMENT WAS COMMENCED, AND THE PATIENT RECEIVED 11 CYCLES OF CHEMOTHERAPY VINCRISTINE, ACTINOMYCIN D, AND CYCLOPHOSPHAMIDE (VAC) REGIMEN. IN (B)(6) 2020, RE-STAGING OF THE PATIENT WAS DONE WITH A CT SCAN REVEALING A MASS MEASURING 14.6X12X6.2 CM IN DIMENSION AROUND THE UMBILICAL/SUB-UMBILICAL AREA WITH INFILTRATION OF RECTUS ABDOMINIS MUSCLES BILATERALLY AND RIGHT EXTERNAL OBLIQUES; NO PERITONEAL INVASION NOTED, NO VISCERAL METASTASIS BUT RIGHT INGUINAL ADENOPATHY. TO COVER THE RESULTANT DEFECT MEASURING 10X14CM IN DIMENSION, AN OMENTAL FLAP WAS MOBILIZED PLACING A LARGE ONLAY (MONOFILAMENT POLYPROPYLENE MESH) BARD MESH, SECURED WITH 3.0& 4.0 VICRYL SUTURE. PATIENT WAS TREATED WITH THE 3 M¿ V.A.C.® THERAPY SYSTEM FOR SEVEN DAYS, CONTINUOUSLY APPLYING AT -100MGHG. THE PATIENT DEMONSTRATED GOOD COMPLIANCE. NO TRAUMA OBSERVED AND NO FISTULA NOTED. TWO YEARS LATER, PATIENT PRESENTED WITH COMPLAINTS OF 1 CM DIAMETER GROWTH THAT WAS FIRM WITH A SMOOTH CONSISTENCY, REGULAR, AND HAD MARGINS THAT WERE FIXED TO THE UNDERLYING STRUCTURES ON THE RIGHT LATERAL MARGIN OF THE TUMOR EXTIRPATION SITE. REPORTED COMPLICATION INCLUDE: PRESENCE OF RECURRENT INTERMEDIATE GRADE SARCOMA, AND A SUSPICIOUS ABDOMINAL WALL LESION WITH NO OVERT INTRA-ABDOMINAL METASTASES. CONCLUSIONS: THE OMENTAL FLAP IS VERSATILE, AND RAISING IT DOES NOT REQUIRE SOPHISTICATED MICROSURGICAL SKILLS. IT ADDS TO THE RECONSTRUCTIVE SURGEON'S ARMAMENTARIUM, ESPECIALLY IN RESOURCE-LIMITED SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258781 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown Required Intervention