BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 14496892 · Received May 25, 2022

    Report

    Report Number
    2210968-2022-04070
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    May 17, 2021
    Report Date
    June 9, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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? CAN YOU IDENTIFY THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT THAT WAS USED IN EACH PROCEDURE? CAN SPECIFIC PATIENT DEMOGRAPHICS INITIALS / ID; 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: GENERAL THORACIC AND CARDIOVASCULAR SURGERY (2021) 69:1407¿1413. HTTPS://DOI.ORG/10.1007/S11748-021-01646-W.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: 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. CAN YOU IDENTIFY THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT THAT WAS USED IN EACH PROCEDURE? 5. CAN SPECIFIC PATIENT DEMOGRAPHICS INITIALS / ID; 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? 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: TITLE: EFFICACY OF PLEURAL COVERAGE WITH POLYGLYCOLIC ACID SHEET AFTER BULLECTOMY FOR POSTOPERATIVE RECURRENCE OF SPONTANEOUS PNEUMOTHORAX IN YOUNG PATIENTS: A MULTI-INSTITUTIONAL COHORT STUDY. AUTHORS: TAKASHI IWAZAWA1,2 · YOSHIHISA KADOTA1,3 · YUKIYASU TAKEUCHI1,4 · HIDEOKI YOKOUCHI1,5 · HIROYUKI SHIONO1,6 · MASANOBU HAYAKAWA1,7 · YASUSHI SAKAMAKI1,8 · EIJI KUROKAWA1,9 · KIYONORI NISHIOKA1,10 · YASUSHI SHINTANI1,11 CITATION: GENERAL THORACIC AND CARDIOVASCULAR SURGERY (2021) 69:1407¿1413. HTTPS://DOI.ORG/10.1007/S11748-021-01646-W THIS MULTI-INSTITUTIONAL RETROSPECTIVE COHORT STUDY AIMED TO EXAMINE THE EFFICIENCY OF PLEURAL COVERAGE FOR THE PREVENTION OF POSTOPERATIVE RECURRENCE IN RELATIVELY YOUNG PATIENTS. BETWEEN JANUARY 2008 AND DECEMBER 2012, A TOTAL OF 357 CASES OF 345 PATIENTS (AGE 15¿29 YEARS) WITH PRIMARY SPONTANEOUS PNEUMOTHORAX WHO UNDERWENT BULLECTOMY AT 13 INSTITUTIONS WERE INCLUDED. A CONCURRENT BILATERAL OPERATION WAS COUNTED AS TWO CASES. THE AVERAGE AGE WAS 20.9 ± 3.8 YEARS, WITH 322 MALE (90.2%) AND 35 FEMALE (9.8%) PATIENTS. POLYGLYCOLIC ACID SHEETS FROM COMPETITOR WERE USED IN 238 CASES, AND OXIDIZED REGENERATED CELLULOSE SHEETS (SURGICEL ABSORBABLE HEMOSTAT, GAUZE TYPE; JOHNSON & JOHNSON LTD., TOKYO, JAPAN) WERE USED IN 37 CASES (30 MALE AND 7 FEMALE; MEAN AGE OF 21.0 ± 3.9 YEARS) TO COVER THE VISCERAL PLEURA, WHILE 82 CASES HAD NO PLEURAL COVERAGE. THE AVERAGE OBSERVATION PERIOD WAS 4.2 ± 2.0 YEARS. REPORTED COMPLICATIONS INCLUDE PNEUMOTHORAX RECURRENCE (N=8) WHICH REQUIRED ASPIRATION OR DRAINAGE IN 2 AND REOPERATION IN 2, WHILE 4 PATIENTS RECEIVED NO TREATMENT OR ONLY REQUIRED REST. IN CONCLUSION, PLEURAL COVERAGE WITH A PGA SHEET WAS SUGGESTED TO BE EFFECTIVE IN PREVENTING POSTOPERATIVE RECURRENCE OF PNEUMOTHORAX COMPARED WITH NON-COVERAGE IN RELATIVELY YOUNGER PATIENTS. FURTHER STUDIES ARE NEEDED TO EVALUATE THE LONG-TERM ADVERSE INFLUENCE OF PLEURAL COVERAGE, SUCH AS DIFFICULTIES IN PERFORMING FUTURE SURGERIES AND PULMONARY DYSFUNCTION DUE TO PLEURAL SYMPHYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267869 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention