BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 9983659 · Received April 21, 2020

    Report

    Report Number
    2210968-2020-03309
    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
    OH, US
    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 INFORMATION WAS REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (PDS II SUTURE, VICRYL 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 PRODUCTS (PDS II SUTURE, VICRYL SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS. CITATION: THE AMERICAN JOURNAL OF SURGERY 217 (2019) 502E506; DOI: HTTPS://DOI.ORG/10.1016/J.AMJSURG.2018.10.034. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: IMPACT OF THE EXTRACTION-SITE LOCATION ON WOUND INFECTIONS AFTER LAPAROSCOPIC COLORECTAL RESECTION" AUTHORS: CIGDEM BENLICE; LUCA STOCCHI; IPEK SAPCI; EMRE GORGUN; HERMANN KESSLER; DAVID LISKA; SCOTT R. STEELE; CONOR P. DELANEY CITATION: THE AMERICAN JOURNAL OF SURGERY 217 (2019) 502E506; DOI: HTTPS://DOI.ORG/10.1016/J.AMJSURG.2018.10.034. THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE IMPACT OF THE INCISION USED FOR SPECIMEN EXTRACTION ON WOUND INFECTION DURING LAPAROSCOPIC COLORECTAL SURGERY. BETWEEN JANUARY 2000 AND DECEMBER 2011, A TOTAL OF 2801 PATIENTS (FEMALE=51.2%; MEAN AGE= 51.0 ± 17.9 YEARS) UNDERWENT LAPAROSCOPIC COLORECTAL RESECTION. DURING THE PROCEDURE, MIDLINE SPECIMEN EXTRACTION FASCIAL WOUNDS WERE CLOSED WITH MASS CLOSURE TECHNIQUES USING 0-MONOFILAMENT, POLYGLYCONATE OR PDS SUTURES (POLYDIOXANE, ETHICON), AND A SUBCUTICULAR, POLYGLACTIN 910 (VICRYL, ETHICON) SUTURE WAS UTILIZED FOR SKIN CLOSURE. A TRANSVERSE CLOSURE OF THE ANTERIOR FASCIA USING RUNNING 1 POLYGLACTIN-910 (VICRYL) WAS CARRIED OUT FOR A MUSCLE-SPLITTING PFANNENSTIEL EXTRACTION SITE. MUSCLE-SPLITTING INCISIONS IN THE RIGHT LOWER QUADRANT AND LEFT LOWER QUADRANT WERE CLOSED WITH A FULL-THICKNESS RUNNING 1 POLYGLACTIN-910 (VICRYL) ENCOMPASSING ALL ABDOMINAL WALL LAYERS. REPORTED COMPLICATION INCLUDED WOUND INFECTION (N=281) IN WHICH 144 WERE CONVERTED TO OPEN SURGERY. IN CONCLUSION, AN EXTRACTION SITE OFF THE MIDLINE IS ASSOCIATED WITH A REDUCED RISK OF SUPERFICIAL SURGICAL SITE INFECTION (SSI), ONCE ALL THE OTHER FACTORS AFFECTING THE DECISION ON WHERE TO EXTRACT THE SPECIMEN ARE CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445276 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention