BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8807047 · Received July 19, 2019

    Report

    Report Number
    3005075853-2019-20519
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    January 1, 2009
    Report Date
    June 21, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2009. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: TREATMENT OF GRADE III AND IV HAEMORRHOIDAL DISEASE WITH PPH OR THD. A RANDOMIZED TRIAL ON POSTOPERATIVE COMPLICATIONS AND SHORT-TERM RESULTS. AUTHORS: SEBASTIAAN FESTEN, M. J. VAN HOOGSTRATEN, A. A. W. VAN GELOVEN AND M. F. GERHARDS. CITATION: INT J COLORECTAL DIS (2009) 24:1401¿1405; DOI 10.1007/S00384-009-0803-2; PUBLISHED ONLINE: 2 OCTOBER 2009. THIS RANDOMIZED TRIAL AIMED TO COMPARE PROCEDURE FOR PROLAPSE AND HAEMORRHOIDS (PPH) AND TRANSANAL HAEMORRHOIDAL DEARTERIALIZATION (THD) IN THE TREATMENT OF GRADE III AND IV HAEMORRHOIDS. BETWEEN DECEMBER 2006 AND NOVEMBER 2007, 41 PATIENTS (AVERAGE AGE WAS 50 YEARS, WITH RANGE FROM 32-79) WITH GRADE III OR IV HEMORRHOIDS WERE INCLUDED IN THE STUDY. EIGHTEEN PATIENTS (MEAN AGE 35 YEARS, MALE/FEMALE RATIO WAS 2.4:1) WERE RANDOMIZED TO PPH TREATMENT AND 23 PATIENTS (MEAN AGE 39 YEARS, MALE/FEMALE RATIO 2.3: 1) TO THD. THE PPH PROCEDURE WAS PERFORMED ACCORDING THE PROTOCOL (PPH 03 STAPLER, ETHICON ENDO-SURGERY). THE STAPLED MUCOSECTOMY WAS PLACED APPROXIMATELY 2 CM ABOVE THE HAEMORRHOIDAL COMPLEX. COMPLICATIONS INCLUDED PERSISTENT ANAL BLOOD LOSS (N=1) WHICH WAS EVENTUALLY TREATED BY HEMORRHOIDECTOMY; PERSISTENT SYMPTOMATIC PROLAPSE (N=2), BLEEDING (N=2) IN WHICH THE PATIENTS WERE ADMITTED TO THE HOSPITAL AND WERE SUCCESSFULLY TREATED BY INTRA-ANAL APPLICATION OF AN IN LIDOCAINE AND ADRENALINE SOAKED GAUZE; BLADDER DYSFUNCTION (N=1) WHICH RESOLVED SPONTANEOUSLY WITHIN 6 WEEKS AND POST-OPERATIVE PAIN VAS SCORE OF 5.1 (RANGE 2-10) ON UNKNOWN NUMBER OF PATIENTS ON DAY 1, 3.2 (RANGE 1-8) ON UNKNOWN NUMBER OF PATIENTS ON DAY 7 AND 1 (RANGE 0-7) ON DAY 21. IN CONCLUSION, PPH AND THD ARE BOTH SAFE TREATMENT OPTIONS WITH GOOD SHORT RESULTS IN THE TREATMENT OF PERSISTENT GRADE III AND IV HAEMORRHOIDAL DISEASE. WE BELIEVE THAT BOTH PROCEDURES CAN BE PERFORMED SIDE BY SIDE IN A SPECIALIZED CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599643 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention