BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 21766864 · Received April 3, 2025

    Report

    Report Number
    2210968-2025-03503
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    August 19, 2024
    Report Date
    April 3, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. 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. 1. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). 2. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? 3. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 4. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 5. CAN SPECIFIC PATIENT DEMOGRAPHICS: INITIALS; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? CITATION: N. SCHMOKE, A. ROSE, C. NEMEH ET AL. / JOURNAL OF PEDIATRIC SURGERY 59 (2024) 161766. 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, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE: THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SCHMOKE N, ROSE A, NEMEH C, WU YS, WANG P, KURLANSKY P, NEUNERT C, MIDDLESWORTH W, DURON V. OPTIMIZING CONGENITAL DIAPHRAGMATIC HERNIA REPAIR ON ECMO: EVALUATING THE RISK OF BLEEDING. J PEDIATR SURG. 2024 DEC;59(12):161766. DOI: 10.1016/J.JPEDSURG.2024.161766. EPUB 2024 AUG 22. PMID: 39271309. OUR STUDY AIMED TO EVALUATE FACTORS ASSOCIATED WITH BLEEDING COMPLICATIONS IN PATIENTS WITH CDH UNDERGOING REPAIR ON ECMO. WE HYPOTHESIZED THAT PATIENTS WITH INCREASED MARKERS OF COAGULOPATHY AT THE TIME OF CDH REPAIR WOULD HAVE INCREASED BLEEDING COMPLICATIONS. A SINGLE-INSTITUTION RETROSPECTIVE REVIEW EVALUATED ALL PATIENTS WITH CDH WHO UNDERWENT ON ECMO REPAIR BETWEEN JANUARY 2005 AND DECEMBER 2023. SURGICEL HEMOSTAT (ETHICON INC., NJ, USA), TACHOSIL FIBRIN SEALANT PATCH (CORZA MEDICAL, MA, USA), AND FLOSEAL HEMOSTATIC MATRIX (BAXTER,IL, USA) WERE USED FOR HEMOSTATIC AGENTS. THE REPORTED COMPLICATIONS INCLUDED BLEEDING (N=11). IN CONCLUSION, THE RISKS AND BENEFITS OF CDH REPAIR ON- VS. OFF-ECMO REQUIRE CAREFUL CONSIDERATION. NEONATES WITH LOWER BIRTH WEIGHTS, PLATELET COUNTS UNDER 100/MM3, ELEVATED BUN, AND OLDER AGE AT THE TIME OF CDH REPAIR ON ECMO HAVE AN INCREASED RISK OF A SIGNIFICANT BLEEDING COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736216 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention