BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 10733216 · Received October 26, 2020

    Report

    Report Number
    2210968-2020-08319
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    January 1, 2018
    Report Date
    October 6, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). (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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (PROLENE 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 (PROLENE SUTURE) USED IN THIS PROCEDURE? WAS THE CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? CITATION: TRANSPLANTATION PROCEEDINGS, 50, 3199E3203 (2018) DOI: HTTPS://DOI.ORG/10.1016/J.TRANSPROCEED.2018.06.005.

    Description of Event or Problem · 1

    TITLE: OPEN MANAGEMENT OF THE RENAL VEIN IS A SAFE MODIFICATION IN RIGHT-SIDED LAPAROSCOPIC LIVING DONOR NEPHRECTOMY TO MAXIMIZE GRAFT VEIN LENGTH. THE GOAL OF THIS STUDY WAS TO DEMONSTRATE THE FEASIBILITY OF A HYBRID TECHNIQUE USING A SATINSKY CLAMP IN RIGHT-SIDED LIVING DONOR NEPHRECTOMY TO OBTAIN MAXIMAL RENAL VEIN AND TO COMPARE THE OUTCOME WITH STANDARD LEFT-SIDED LAPAROSCOPIC DONOR NEPHRECTOMIES. BETWEEN 2005 AND 2013, 77 PATIENTS UNDERWENT A LEFT (GROUP L) AND 54 A RIGHT (GROUP R) LIVING DONOR NEPHRECTOMY. INFERIORLY, THE URETER WAS CLOSED WITH ONE LARGE TITANIUM CLIP (ETHICON). THE VENOTOMY WAS THEN CLOSED WITH A RUNNING 4-0 PROLENE SUTURE (ETHICON) IN GROUP R. IN THE EARLY POSTOPERATIVE PERIOD, A LAPAROTOMY HAD TO BE PERFORMED DUE TO A SMALL BOWEL OBSTRUCTION IN A R-LDN PATIENT AT POSTOPERATIVE DAY 7 (N=1). OPEN MANAGEMENT OF THE RENAL VEIN IS A SAFE ALTERNATIVE IN LAPAROSCOPIC RIGHT-SIDED DONOR NEPHRECTOMY AND ENSURES MAXIMAL LENGTH OF THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198239 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention