BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 12586141 · Received October 6, 2021

    Report

    Report Number
    2210968-2021-09284
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    January 1, 2020
    Report Date
    September 14, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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 AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OPERATIVE SURGICAL SITE INFECTION FOR IDENTIFIED 7 PATIENTS IN CONTROL GROUP AND 9 PATIENTS IN CHG GROUP DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE SUTURE) USED IN ALL THESE CASES DESCRIBED IN THIS STUDY? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION CITE:SURGICAL INFECTIONS VOLUME 21, NUMBER 2, 2020 . MARY ANN LIEBERT, INC. DOI: 10.1089/SUR.2019.053. (B)(4): EVENTS WERE SUBMITTED VIA 2210968-2021-09226, 2210968-2021-09273, 2210968-2021-09274, 2210968-2021-09276, 2210968-2021-09277, 2210968-2021-09279, 2210968-2021-09280, 2210968-2021-09281, 2210968-2021-09285, 2210968-2021-09286, 2210968-2021-09287, 2210968-2021-09288, 2210968-2021-09289, 210968-2021-09290 AND 2210968-2021-09291 (B)(4) : EVENTS WERE SUBMITTED VIA 2210968-2021-09166, 2210968-2021-09167, 2210968-2021-09168, 2210968-2021-09169, 2210968-2021-09170, 2210968-2021-09171, 2210968-2021-09172, 2210968-2021-09173, 2210968-2021-09174, 2210968-2021-09175, 2210968-2021-09176, 2210968-2021-09177, 2210968-2021-09178, 2210968-2021-09179, 2210968-2021-09180, 2210968-2021-09181, 2210968-2021-09183, 2210968-2021-09184, 2210968-2021-09185 AND 2210968-2021-09186.

    Description of Event or Problem · 1

    TITLE: WOUND IRRIGATION WITH CHLORHEXIDINE GLUCONATE REDUCES SURGICAL SITE INFECTION IN PILONIDAL DISEASE:SINGLE-BLIND PROSPECTIVE STUDY. THE AIM OF THIS STUDY WAS TO DETERMINE WHETHER INCISION IRRIGATION WITH CHLORHEXIDINE GLUCONATE (CHG) REDUCES SURGICAL SITE INFECTIONS (SSIS) IN PILONIDAL DISEASE SURGERY. 298 PATIENTS ENROLLED IN THE DATABASE BETWEEN 2013 AND 2018, PATIENTS WHO UNDERWENT WIDE EXCISION WITH PRIMARY CLOSURE FOR PILONIDAL DISEASE WERE ENROLLED IN THIS PROSPECTIVE OBSERVATIONAL MULTI INSTITUTIONAL COHORT. THE INCISION WAS IRRIGATED WITH EITHER SALINE OR 0.05% CHG BEFORE SKIN CLOSURE. ALL THE PROCEDURES WERE PERFORMED WITH THE PATIENT UNDER SPINAL ANESTHESIA IN THE PRONE POSITION. ANTIBIOTIC PROPHYLAXIS WAS GIVEN 30 MINUTES BEFORE INCISION WITH 1.5 G OF CEFUROXIME AXETIL AND 500 MG OF METRONIDAZOLE. THE SURGICAL SITE WAS SHAVED, AND SKIN ANTISEPSIS WAS PROVIDED WITH POVIDONE¿IODINE. THE PILONIDAL CYST WAS REMOVED WITH CLEAN SURGICAL BORDERS. THE WOUND WAS IRRIGATED FOR ONE MINUTE, 1-0 MONOFILAMENT POLYPROPYLENE (PROLENE ; ETHICON, SOMERVILLE, NJUSA) RETENTION SUTURESWERE PREPARED, AND THE SUBCUTANEOUS TISSUE WAS CLOSED WITH 3-0 POLYGLACTIN (VICRYL ETHICON) SUTURES. SKIN CLOSURE WAS CREATED WITH INTERRUPTED 3-0 POLYPROPYLENE (PROLENE, ETHICON), AND RETENTION SUTURES WERE TIED OVER A COMPRESSION GAUZE. REPORTED COMPLICATIONS INCLUDED: CHLORHEXIDINE GLUCONATE (CHG), PATIENT 2 (B)(6) YEARS OLD MALE POSTOPERATIVE SURGICAL SITE INFECTION, IN CONCLUSION INTRA-OPERATIVE INCISION IRRIGATION WITH CHG DECREASED THE SSI RATE AND TIME TO HEALING IN PILONIDAL DISEASE SURGERY. FURTHER RANDOMIZED TRIALS SHOULD FOCUS ON SPECIFIC IRRIGATION METHODS AND PROCEDURES TO BUILD A CONSENSUS ON THE EFFECT OF INCISION IRRIGATION ON SSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484098 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR