BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19151524 · Received April 22, 2024

    Report

    Report Number
    2210968-2024-04637
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    May 20, 2022
    Report Date
    April 22, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. RELATED EVENTS CAPTURED VIA 2210968-2024-04638. CITATION: J. CLIN. MED. 2022, 11, 2887. HTTPS://DOI.ORG/10.3390/JCM11102887.

    Description of Event or Problem · 0

    TITLE: THE USE OF CLOSED INCISION NEGATIVE PRESSURE THERAPY ON THE MEDIAL THIGH DONOR SITE IN TRANSVERSE MUSCULOCUTANEOUS GRACILIS FLAP BREAST RECONSTRUCTION THE OBJECTIVE OF THIS STUDY IS TO EXAMINE THE IMPACT OF CLOSED INCISION NEGATIVE PRESSURE THERAPY (CINPT) ON DONOR SITE COMPLICATIONS AND PATIENT PERCEPTIONS IN TRANSVERSEMUSCULOCUTANEOUS GRACILIS (TMG) FLAP BREAST RECONSTRUCTION. BETWEEN 1 JANUARY 2010 TO 31 DECEMBER 2021, A TOTAL OF 56 PATIENTS WITH 83 TMG FLAPS WERE INCLUDED (CONTROL GROUP:35 PATIENTS WITH 53 TMG FLAPS; CINPT GROUP: 21 PATIENTS WITH 30 TMG FLAPS). THE INCIDENCE OF TOTAL SURGICAL SITE COMPLICATIONS ON THE MEDIAL THIGH DONOR SITE WAS REDUCED IN THE CINPT GROUP COMPARED TO THE CONTROL, WITHOUT STATISTICAL DIFFERENCE (CONTROL GROUP 50.9% VS. CINPT GROUP 30.0%). THE INCIDENCE OF NON-OPERATIVE SURGICAL SITE COMPLICATIONS (CONTROL GROUP 24.5% VS. CINPT GROUP 10.0%) AND OPERATIVE SURGICAL SITE COMPLICATIONS (CONTROL GROUP 26.4% VS. CINPT GROUP 20.0%) WAS NOT STATISTICALLY DIFFERENT BETWEEN BOTH GROUPS. THERE WAS NO DIFFERENCE IN FLUID DRAINAGE AND TIME TO DRAIN REMOVAL. SIMILARLY, NO SKIN IRRITATIONS OR LOCAL PAIN APPEARED IN THE CINPT GROUP. DIMINISHMENT IN MOVEMENT WAS A MINOR COMPLAINT. THE MAJORITY OF PATIENTS STATED THEY FELT PROTECTED BY CINPT APPLICATION AND WOULD CHOOSE CINPT FOR INCISION MANAGEMENT IN THE FUTURE. FIRSTLY, A FEW INVERTED INTERRUPTED SUTURES WERE PERFORMED FOR THE REDUCTION IN THE DEAD SPACE OF THE DEEP SOFT TISSUE (VICRYL 0, ETHICON, NORDERSTEDT, GERMANY). SECONDLY, INVERTED INTERRUPTED SUTURES WERE USED FOR THE CLOSURE OF THE SUBCUTANEOUS TISSUE (MONOCRYL 2.0, ETHICON, NORDERSTEDT, GERMANY). LASTLY, SKIN CLOSURE WAS PERFORMED WITH A CONTINUOUS INTRACUTANEOUS SUTURE (MONOCRYL 3.0, ETHICON, NORDERSTEDT, GERMANY). REPORTED COMPLICATIONS FOR CINPT GROUP: OPERATIVE SURGICAL SITE COMPLICATIONS (N=6): SEROMA (N=1), SKIN NECROSIS (N=3), HEMATOMA (N=1), WOUND INFECTION (N=1); NON-OPERATIVE SURGICAL SITE COMPLICATIONS (N=3): DELAYED WOUND HEALING (N=2), SEROMA (N=1), DIMINISHMENT IN MOVEMENT (N=?) AND FOR CONTROL GROUP: OPERATIVE SURGICAL SITE COMPLICATIONS (N=14): SEROMA (N=2), SKIN NECROSIS (N=3), HEMATOMA (N=2), WOUND INFECTION (N=2), WOUND DEHISCENCE (N=5); NON-OPERATIVE SURGICAL SITE COMPLICATIONS (N=13): DELAYED WOUND HEALING (N=5), SEROMA (N=5), HEMATOMA (N=1), AND WOUND INFECTION (N=1). IN CONCLUSION, EVIDENCE EXISTS FOR THE SUPERIORITY OF CINPT COMPARED TO CONVENTIONAL WOUND MANAGEMENT ON THE DONOR SITE IN PATIENTS UNDERGOING FREE FLAP BREAST RECONSTRUCTION FROM THE LOWER ABDOMEN. HOWEVER, THE PRESENT STUDY FAILS TO PROVIDE COMPELLING EVIDENCE FOR CINPT TO ENHANCE INCISION HEALING ON THE DONOR SITE IN THE PATIENTS UNDERGOING TMG FLAP BREAST RECONSTRUCTION. OUR PRELIMINARY DATA STILL SHOW A TREND TOWARDS LOWER SURGICAL SITE COMPLICATIONS ON THE MEDIAL THIGH DONOR SITE AND A SHORTENED IN-HOSPITAL STAY. THIS IS THE FIRST STUDY TO DISCLOSE THAT PATIENTS FEEL PROTECTED BY PROPHYLACTIC CINPT APPLICATION AND PATIENT DISCOMFORT COULD BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593589 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other