BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 9980888 · Received April 21, 2020

    Report

    Report Number
    2210968-2020-03257
    Event Type
    Injury
    Date Received
    April 21, 2020
    Report Date
    March 27, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER FOR EACH PATIENT? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (PDS II SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (PDS II SUTURE) INVOLVED? PATIENT DEMOGRAPHICS? CITATION: SCIENTIFIC REPORTS; (2018) 8:12942; DOI:10.1038/S41598-018-31287-8. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: A COMBINATION OF SUBCUTICULAR SUTURE AND ENHANCED RECOVERY AFTER SURGERY REDUCES WOUND COMPLICATIONS IN PATIENTS UNDERGOING HEPATECTOMY FOR HEPATOCELLULAR CARCINOMA". AUTHORS: ZU-SHUN CHEN; SHAO-LIANG ZHU; LU-NAN QI; LE-QUN LI. CITATION: SCIENTIFIC REPORTS; (2018) 8:12942; DOI:10.1038/S41598-018-31287-8. THE AIMED OF THIS PROSPECTIVE STUDY WAS TO EXAMINE WHETHER USING SUBCUTICULAR SUTURES DURING INITIAL HEPATECTOMY FOR HEPATOCELLULAR CARCINOMA (HCC) IS ASSOCIATED WITH SHORTER POSTOPERATIVE LENGTH OF HOSPITAL STAY (PLOS) THAN USING STAPLES FOR PATIENT TREATED IN THE ENHANCED RECOVERY AFTER SURGERY (ERAS) APPROACH. BETWEEN JANUARY 2012 AND JULY 2017, A TOTAL OF 376 PATIENTS WERE RANDOMIZED TO RECEIVE EITHER SUBCUTICULAR SUTURES OR STAPLES DURING HEPATECTOMY. SUBCUTICULAR SUTURE GROUP (MALE=135, FEMALE=53; MEAN AGE=52.33 ± 11.29 YEARS; MEAN BMI=25.34 ± 5.25 KG/M^2) WHEREAS STAPLES GROUP (MALE=131, FEMALE=57; MEAN AGE=52.19 ± 10.95 YEARS; MEAN BMI=25.13 ± 5.51 KG/M^2). IN THE GROUP RECEIVING SUBCUTICULAR SUTURES, THE FASCIA WAS CLOSED USING INTERRUPTED SUTURES WITH 0 OR 1 ABSORBABLE MONOFILAMENT POLYDIOXANONE SUTURE (PDS II, ETHICON), AND THE SUBCUTANEOUS SPACE WAS IRRIGATED WITH SALINE WITHOUT ANTIBIOTICS. INTERRUPTED SUBCUTICULAR SUTURES WITH A 4-0 MONOFILAMENT ABSORBABLE POLYDIOXANONE SUTURE (PDS II, ETHICON) WAS ALSO USED. THE SUTURE INTERVAL WAS 15 ¿ 25 MM, AND SUTURE BITE LENGTH WAS 15-25 MM FROM THE EDGE OF THE SKIN TO PROVIDE TIGHT SKIN CLOSURE. REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N=8), WOUND SEPARATION (N=5); BLOOD LOSS (N=?) DURING SURGERY OF 400 ML OR LESS, IN WHICH 18 PATIENTS HAD INTRAOPERATIVE BLOOD TRANSFUSION. IN CONCLUSION, THE STUDY PROVIDES THE FIRST EVIDENCE THAT SUBCUTICULAR SUTURING MAY BE MORE EFFECTIVE THAN STAPLES FOR HCC PATIENTS UNDERGOING HEPATECTOMY WITHIN AN ERAS APPROACH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446440 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention