BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 12701261 · Received October 26, 2021

    Report

    Report Number
    2210968-2021-10361
    Event Type
    Injury
    Date Received
    October 26, 2021
    Date of Event
    February 11, 2021
    Report Date
    January 12, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 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? EVENT RELATED TO MW # 2210968-2021-10362. CITATION CITE: TURK J MED SCI (2021) 51: 1388-1395; DOI:10.3906/SAG-2008-78.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION; H6. HEALTH EFFECT - IMPACT CODE. 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: EFFECTS OF INTRAOPERATIVE BLOOD LOSS DURING LIVER RESECTION ON PATIENTS¿ OUTCOME: A SINGLECENTER EXPERIENCE. AUTHORS: MUHAMMED SELIM BODUR, KADIR TOMAS, SERDAR TOPALOGLU, SÜKRÜ OGUZ, HAKAN KÜÇÜKASLAN, DAVUT DOHMAN, ERDEM KARABULUT, ADNAN ÇALIK. CITATION CITE: TURK J MED SCI (2021) 51: 1388-1395; DOI:10.3906/SAG-2008-78. THIS STUDY AIMED TO DESCRIBE THE IMPACT OF INTRAOPERATIVE BLOOD LOSS ON THE POSTOPERATIVE COURSE OF LIVER RESECTION (LR). THE DATA OF 257 PATIENTS WHO WERE TREATED WITH LR BETWEEN JANUARY 2007 AND OCTOBER 2018 WERE RETROSPECTIVELY ANALYZED. LRS WERE PERFORMED VIA INTERMITTENT PORTAL TRIAD CLAMPING (PTC) UNDER LOW CENTRAL VENOUS PRESSURE. THE WHOLE PART OF THE CUT SURFACE WAS THEN COATED WITH OXIDIZED CELLULOSE (SURGICEL FIBRILLAR, ETHICON SÀRL, PUITS-GODET 20, NEUCHÂTEL, SWITZERLAND). RESECTION OF COMMON HEPATIC DUCT WAS REQUIRED IN PATIENTS WITH KLATSKIN TUMOR (N = 22/22) AND ALVEOLAR HYDATID DISEASE (N = 3/16) RELATED TO DISEASE INVASION OR DISEASE EXTENSION (IN A PATIENT WITH HEPATHOLITHIASIS). HEPATICOJEJUNOSTOMY WAS CARRIED OUT WITH INTERRUPTED 5/0 POLYDIOXANONE (PDS) SUTURES (ETHICON). THE FASCIAL PLANES OF THE INCISION WERE CLOSED WITH A RUNNING NO. 1 PDS SUTURE (ETHICON). REPORTED COMPLICATIONS INCLUDED BILIARY LEAK (N=11), , BILIARY OBSTRUCTION (N = 1), BILIOENTERIC ANASTOMOSIS (N = 5), PERCUTANEOUS DRAINAGE (N =10). SURGICAL SITE INFECTIONS (N=15), POSTOPERATIVE BLEEDING (N=1), DEHISCENCE (N=3) IN CONCLUSION, DIFFERENT METHODS ARE USED IN COMBINATION TO CONTROL BLEEDING DURING LIVER SURGERY. EACH STEP OF BLEEDING CONTROL IN THIS STUDY IS BASED ON WELLACCEPTED APPLICATIONS AND TRUSTED DEVICES OR TOPICAL AGENTS. MORBIDITY AND MORTALITY RATES AND BLEEDING AMOUNTS ARE FOUND WITHIN ACCEPTABLE RANGES INDICATED IN THE LITERATURE. ALTHOUGH INTENSIVE EFFORTS HAVE BEEN DEVOTED TO CONTROLLING BLEEDING, OPERATIVE BLEEDING REMAINS A MAJOR DETERMINANT OF MORBIDITY AND MORTALITY IN LIVER SURGERY. HOWEVER, FAVORABLE OUTCOMES OBTAINED WITH DILIGENT POSTOPERATIVE CARE CAN ENCOURAGE SURGEONS TO ACHIEVE BETTER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598045 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention