BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15465695 · Received September 22, 2022

    Report

    Report Number
    2210968-2022-07780
    Event Type
    Injury
    Date Received
    September 22, 2022
    Report Date
    September 28, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 09/21/2022. 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, 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. (B)(4). 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.  CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH VOLUME 31, NUMBER 5, OCTOBER 2021 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (SECURESTRAP, SUTURE) 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 THE ETHICON PRODUCTS INVOLVED? PATIENT DEMOGRAPHICS ADVERSE EVENTS RELATED TO SUTURE REPORTED VIA MW# 2210968-2022-07780. ADVERSE EVENTS RELATED TO SECURESTRAP REPORTED VIA MW# 2210968-2022-07781. ADVERSE EVENTS RELATED TO SUTURE FOR 52-YEAR-OLD MALE PATIENT REPORTED VIA MW# 2210968-2022-07782. ADVERSE EVENTS RELATED TO SECURESTRAP FOR 52-YEAR-OLD MALE PATIENT REPORTED VIA MW# 2210968-2022-07783. ADVERSE EVENTS RELATED TO SUTURE FOR 41-YEAR-OLD FEMALE PATIENT REPORTED VIA MW# 2210968-2022-07784. ADVERSE EVENTS RELATED TO SECURESTRAP FOR 41-YEAR-OLD FEMALE PATIENT REPORTED VIA MW# 2210968-2022-07785.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: SIMULTANEOUS SMALL/MEDIUM UMBILICAL HERNIA REPAIR WITH\ LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG): RESULTS OF A RETROSPECTIVE CASE-MATCHED STUDY. THE AIM OF THIS STUDY WAS TO ASSESS THE FEASIBILITY AND COMPARE OUTCOMES OF A SIMULTANEOUS PROCEDURE VERSUS A DELAYED INTERVENTION OF PERIUMBILICAL HERNIOPLASTY IN PATIENTS UNDERGOING LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG). FROM JANUARY 1, 2010 TO DECEMBER 31, 2018, 40 PATIENTS WERE DIVIDED INTO 2 MATCHED GROUPS OF 20 SUBJECTS EACH; THE FIRST GROUP UNDERWENT LSG WITH SIMULTANEOUS PERIUMBILICAL HERNIA REPAIR; IN THE SECOND, HERNIOPLASTY WAS PERFORMED AFTER WEIGHT LOSS INDUCED BY LSG. A 10MM TROCAR WITH OPTIVIEW TECHNOLOGY (JOHNSON & JOHNSON MEDICAL NV) WAS PLACED INTO THE UMBILICUS DEFECT AFTER USING OTHER ACCESSES TO REDUCE THE HERNIA CONTENT. AN INTRAPERITONEAL MESH (DUAL-MESH; GORE MEDICAL) WAS FIXED TO COVER THE DEFECT WITH A ROUND OF ABSORBABLE TACKS (SECURESTRAP; JOHNSON & JOHNSON MEDICAL). VICRYL 2/0 SUTURES AND POLYPROPYLENE 0 AND 2/0 WERE ALSO USED FOR SUBJECTS WITH OPEN ONLAY REPAIR. ALL PATIENTS UNDERWENT ROUTINE BARIATRIC FOLLOW-UP 7 DAYS AFTER SURGERY AND AT 1, 3, 6, 12, AND 24 POSTOPERATIVE MONTHS. DELAYED PROCEDURE GROUP (N=2) RECURRENCE, 52-YEAR-OLD MALE SUBJECT WITH A BODY MASS INDEX (BMI) OF 35 KG/M2, 41-YEAR-OLD FEMALE WITH A BMI 30 KG/M2, (N=1) TROCAR SITE HEMATOMA , (N=1) SEROMA, (N=1) INFECTION, (N=2) REOPERATION. SIMULTANEOUS PROCEDURE GROUP, (N=1) TROCAR SITE HEMATOMA. IN THE CASE OF MORBIDLY OBESE PATIENTS WITH SMALL/ MEDIUM PERIUMBILICAL HERNIA UNDERGOING LSG, A SIMULTANEOUS APPROACH SHOULD BE OFFERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2551748 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.
    2856844 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention