BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 16912862 · Received May 11, 2023

    Report

    Report Number
    2210968-2023-03533
    Event Type
    Injury
    Date Received
    May 11, 2023
    Report Date
    May 11, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. H 6. HEALTH EFFECT - CLINICAL CODE : E2401 ¿ HYDROCEPHALUS, E2401 ¿ CHIARI MALFORMATION. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 6. 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: J NEUROSURG PEDIATR 28:579¿584, 2021 EVENT RELATED TO MW # 2210968-2023-03532. 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: TITLE: STANDARDIZING POSTOPERATIVE CARE FOR PEDIATRIC INTRADURAL CHIARI DECOMPRESSIONS TO DECREASE LENGTH OF STAY AUTHOR: DAVID J. MAZUR-HART, MD, MS, STEPHEN G. BOWDEN, MD, BRANDI W. PANG, BS, NASSER K. YAGHI, MD, JOSEPH G. NUGENT, MHS, LAURIE D. YABLON, RN, MS, CPNP, WENDY O. DOMREIS, MS, RN, CPNP, ERIKA T. OHM, RN, MN, CPNP, AND CHRISTINA M. SAYAMA, MD, MPH CITATION: J NEUROSURG PEDIATR 28:579¿584, 2021 IN THIS STUDY, THE AUTHORS AIMED TO EXAMINE WHETHER INSTITUTING A STANDARDIZED POSTOPERATIVE CARE PROTOCOL WOULD DECREASE OVERALL PATIENT HOSPITAL LENGTH OF STAY (LOS) AS WELL AS COST TO FAMILIES AND THE HOSPITAL SYSTEM. A RETROSPECTIVE STUDY OF PEDIATRIC PATIENTS WHO UNDERWENT AN INTRADURAL CHIARI DECOMPRESSION WITH EXPANSILE DURAPLASTY AT A SINGLE INSTITUTION FROM JANUARY 2016 TO SEPTEMBER 2019 WAS PERFORMED. A STANDARDIZED POSTOPERATIVE CARE PROTOCOL WAS INSTITUTED ON MAY 17, 2018. PRE- AND POSTPROTOCOL GROUPS WERE PRIMARILY ANALYZED FOR DEMOGRAPHICS, LOS, AND THE ESTIMATED FINANCIAL EXPENSE OF THE HOSPITAL STAY. THE ANALYSIS INCLUDED 132 PEDIATRIC PATIENTS WHO UNDERWENT AN INTRADURAL CHIARI DECOMPRESSION WITH EXPANSILE DURAPLASTY. THE PREPROTOCOL GROUP INCLUDED 97 PATIENTS AND THE POSTPROTOCOL GROUP INCLUDED 35 PATIENTS. PATIENT AGE RANGED FROM 0.5 TO 26 YEARS (MEAN 9.5 YEARS). THE MEAN LOS PREPROTOCOL WAS 55.48 HOURS (RANGE 25.90¿127.77 HOURS), AND THE MEAN POST PROTOCOL LOS WAS 46.39 HOURS (RANGE 27.58¿77.38 HOURS). FOR THE DURAPLASTY, THE DURAL GRAFT WAS AN ARTIFICIAL SUBSTITUTE AND SUTURED WATERTIGHT. A DURAL SEALANT WAS APPLIED TO THE SUTURE LINES. ONE ATTENDING SURGEON LINED THE SUTURE EDGES WITH FIBRILLAR (ETHICON US, LLC) BEFORE APPLYING A DURAL SEALANT. ONE ATTENDING SURGEON USED 6-0 GORE-TEX (W. L. GORE & ASSOCIATES, INC.) SUTURES FOR THE DURAL CLOSURE, WHILE THE OTHER TWO SURGEONS USED 4-0 NUROLON (ETHICON US, LLC) SUTURES. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: READMISSIONS: (N=5) SYMPTOMS ATTRIBUTABLE TO POSTOPERATIVE CHIARI DECOMPRESSION (HEADACHES, CONSTIPATION, AND VOMITING). (N=2) POSTOPERATIVE WOUND INFECTIONS . (N=4) PRESENTED WITH MIXED HYDROCEPHALUS AND CHIARI MALFORMATION CLINICAL PICTURES. (N=1) VOMITING AND INABILITY TO TOLERATE TUBE FEEDING . IN CONCLUSION, BY INSTITUTING A CHIARI PROTOCOL, POSTOPERATIVE LOS WAS SIGNIFICANTLY DECREASED, WHICH RESULTED IN DECREASED HEALTHCARE COSTS WHILE MAINTAINING HIGH-QUALITY AND SAFE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603983 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention