BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 16929891 · Received May 15, 2023

    Report

    Report Number
    2210968-2023-03578
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    April 28, 2022
    Report Date
    May 15, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IT WAS REPORTED VIA A JOURNAL ARTICLE: H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. H6. 6. HEALTH EFFECT - IMPACT CODE : F24 - RECURRENCE WAS TREATED WITH OBSERVATION IN 15 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. 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: BMJ OPEN RESP RES 2022;9:E001231. DOI:10.1136/BMJRESP-2022-001231. 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: COMPARISON OF THE EFFICACY OF NOVEL TWO COVERING METHODS FOR SPONTANEOUS PNEUMOTHORAX: A MULTI-INSTITUTIONAL STUDY AUTHORS: RISA ODA,1 KATSUHIRO OKUDA,1 TAKESHI YAMADA,2 HARUHIRO YUKIUE,2 ICHIRO FUKAI,3 OSAMU KAWANO,3 TAKUYA MATSUI,1 TSUTOMU TATEMATSU,1 KEISUKE YOKOTA,1 RYOICHI NAKANISHI 1 CITATION: BMJ OPEN RESP RES 2022;9:E001231. DOI:10.1136/BMJRESP-2022-001231 THIS RETROSPECTIVE STUDY WAS CONDUCTED TO ELUCIDATE AN EFFECTIVE TECHNIQUE FOR IMPROVING THE POSTOPERATIVE RECURRENCE RATE. A TOTAL OF 373 PATIENTS (344 MALE AND 29 FEMALE; MEDIAN AGE WAS 20 (14¿30) YEARS) WHO UNDERWENT THORACOSCOPIC BULLECTOMY FOR PRIMARY SPONTANEOUS PNEUMOTHORAX (PSP) AT THREE HOSPITALS FROM JANUARY 2013 TO MAY 2020. THESE PATIENTS WERE DIVIDED INTO TWO GROUPS ACCORDING TO THE METHODS USED TO COVER THE STAPLE LINE AFTER THORACOSCOPIC BULLECTOMY AND WERE COMPARED. GROUP A (N=146; 136 MALE AND 10 FEMALE; MEDIAN AGE WAS 19 (14¿30) YEARS) WAS TREATED WITH AN ABSORBABLE POLYGLYCOLIC ACID (PGA) SHEET (NEOVEIL, 10×5 CM; (B)(6), JAPAN) PLUS FIBRIN GLUE AND THE LESION WAS THEN COVERED WITH AN ORC (SURGICEL ABSORBABLE HEMOSTAT, 5.1×7.6 CM; ETHICON, USA) SHEET. GROUP B (N=227; 208 MALE AND 19 FEMALE; MEDIAN AGE WAS 20 (14¿30) YEARS) WAS TREATED WITH ORC ALONE. REPORTED COMPLICATIONS INCLUDE POSTOPERATIVE RECURRENT PNEUMOTHORAX (N=44). IN CONCLUSION, COVERAGE WITH A PGA SHEET MAY PREVENT THE POSTOPERATIVE RECURRENCE OF PSP. A LARGE-SCALE PROSPECTIVE RANDOMISED STUDY SHOULD BE CONDUCTED TO CLARIFY THE MOST EFFECTIVE TREATMENT FOR PSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351666 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other