BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8724353 · Received June 21, 2019

    Report

    Report Number
    2210968-2019-83120
    Event Type
    Injury
    Date Received
    June 21, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: EFFECTIVE TREATMENT OF HAEMORRHOIDS: EARLY COMPLICATION AND LATE RESULTS AFTER 150 CONSECUTIVE STAPLED HAEMORRHOIDECTOMIES" AUTHOR(S): ALDO BOVE, GIUSEPPE BONGARZONI, GINO PALONE, STELLA CHIARINI, ENRICO MARIA CALISESI, LUCIANO CORBELLINI CITATION: ANN. ITAL. CHIR., 2009; 80: 299-303. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFICACY OF HAEMORRHOIDECTOMY (LONGO¿S PROCEDURE), THE EARLY AND ESPECIALLY LATE COMPLICATIONS, AND RECURRENCES, IN 150 PATIENTS. BETWEEN JAN 2005 TO DEC 2006, A TOTAL OF 150 PATIENTS [N=67 MEN, N=83 FEMALE, MEAN AGE 42 YEARS (RANGE 25 TO 72 YEARS)] WITH THIRD AND FOURTH DEGREE HAEMORRHOIDS UNDERWENT HAEMORRHOIDECTOMY. KIT PPH01 WAS USED, A GENTLE AND PROGRESSIVE REDUCTION OF THE PROLAPSE WITH A DEDICATED TOOL WAS MADE. FOLLOWED BY A PURSE-STRING SUTURE MADE WITH PROLENE 0 TO ACHIEVE A MUCO-MUCOSA ANASTOMOSIS AT LEAST 4 CENTIMETERS ABOVE THE PECTINATE LINE. THE TOOL WAS HELD CLOSED FOR ONE MINUTE FOLLOWING THE EXECUTION OF THE ANASTOMOSIS AND THEN ROUTINELY INSERTED FEW ADDITIONAL STITCHES IN ORDER TO PREVENT BLEEDING. EARLY COMPLICATIONS INCLUDED BLEEDING (N=5) IN WHICH 3 EARLY BLEEDINGS OCCURRED WITHIN THE FIRST 12 HOURS REQUIRED SURGICAL REPAIR BUT NO BLOOD TRANSFUSION; THE 2 LATE BLEEDINGS WHICH APPEARED 7 DAYS AFTER THE OPERATION WERE DUE TO A PARTIAL DETACHMENT OF THE PERIANASTOMOTIC MUCOSA WHICH NECESSITATED A RE-OPERATION WITH BLOOD TRANSFUSION; AND HAEMATOMA OF THE RECTUS WALL (N=1) WHICH NECESSITATED THE SURGICAL INSERTION OF A DRAIN. LATE COMPLICATIONS INCLUDED FAECAL URGENCY (N=5) WHICH DISAPPEARED WITHOUT TREATMENT AFTER 6 MONTHS; MODERATE ASYMPTOMATIC STRICTURES (N=6); PERSISTENT SKIN TAGS (N=4); AND RECURRENCES (N=8) WITHIN 24 MONTHS FROM SURGERY. THE STAPLED PROCEDURE ACCORDING TO LONGO IS AN EFFECTIVE TREATMENT FOR HAEMORRHOIDS. THE RESULTS FOR POSTOPERATIVE PAIN AND EARLY RETURN TO WORK ARE VERY GOOD. HOWEVER, SPECIAL CARE FOR HAEMOSTASIS IS ESSENTIAL IN ORDER TO AVOID BLEEDING. AN EFFECTIVE SURGICAL TECHNIQUE PREVENTS LATE COMPLICATIONS, BUT RESULTS AFTER LONG TERM FOLLOW UP SHOW A NOT INSIGNIFICANT PERCENTAGE OF RECURRENCES THAT APPEARED ESPECIALLY IN THE FOURTH DEGREE HAEMORRHOIDS. THEREFORE, A CAREFUL PRE-OPERATIVE EXCLUSION OF THOSE PATIENTS WITH A PROMINENT PROLIX IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518675 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention