BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROTACK

    MDR report key: 8733288 · Received June 26, 2019

    Report

    Report Number
    2647580-2019-03253
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    May 20, 2009
    Report Date
    June 25, 2019
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: LONG-TERM RESULTS OF LAPAROSCOPIC REPAIR OF INCISIONAL HERNIAS USING AN INTRAPERITONEAL COMPOSITE MESH / SOURCE: ALFREDO MORENO-EGEA Æ JOSE´ ANTONIO CASTILLO BUSTOS Æ ENRIQUE GIRELA Æ JOSE´ LUIS AGUAYO-ALBASINI / 27 JANUARY 2009 / ACCEPTED: 20 MAY 2009 / PUBLISHED ONLINE: 17 JUNE 2009 SPRINGER SCIENCE+BUSINESS MEDIA, LLC 2009. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4)].

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, (JANUARY 1994 AND DECEMBER 2006), THIS STUDY AIMED TO EVALUATE THE LONG-TERM COMPLICATIONS AND RECURRENCES OF LAPAROSCOPIC REPAIR OF INCISIONAL HERNIAS. DATA FOR 200 CONSECUTIVE PATIENTS WHO UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR (LIHR) IN A UNIVERSITY TEACHING HOSPITAL ERE COLLECTED PROSPECTIVELY. THE MEDIAN FOLLOW-UP WAS 6 (RANGE, 1¿12) YEARS. A DOUBLE-LAYER MESH WAS USED IN ALL CASES. ONCE THE MESH WAS PLACED OVER THE DEFECT, IT WAS FASTENED WITH A CROWN OF HELICAL STAPLES. THE POSTOPERATIVE COMPLICATIONS ARE SHOWN IN TABLE 2 OF THE ARTICLE. THERE WAS AN OVERALL POSTOPERATIVE COMPLICATION RATE OF 15%. TWENTY-THREE PATIENTS (11.5%) HAD EARLY (\30 DAYS) POSTOPERATIVE COMPLICATIONS, INCLUDING HEMATOMA, SEROMA, TROCAR SITE INFECTION, AND PROLONGED ILEUS, WHICH RESOLVED SPONTANEOUSLY ON POSTOPERATIVE DAY 2. LATE ([30 DAYS) POSTOPERATIVE COMPLICATIONS OCCURRED IN SEVEN PATIENTS (3.5%) AND INCLUDED ORGANIZED HEMATOMA AND BOWEL OBSTRUCTION IN ONE CASE (0.5%). THESE PATIENTS UNDERWENT REOPERATION AND THE CAUSE WAS ENTERO-ENTERIC ADHESIONS (NOT THE MESH OR TACKS). POSTOPERATIVE PAIN WAS LIMITED, WITH A MEAN ANALGESIC REQUIREMENT OF 6.8 ± 7.3 (RANGE, 0¿30) DAYS. ELEVEN RECURRENCES (6.2%) WERE DIAGNOSED DURING A MEAN FOLLOW-UP TIME OF 60 (RANGE, 12¿144) MONTHS IN THOSE WHO WERE AVAILABLE FOR ASSESSMENT (178 PATIENTS). THE REASON FOR THESE RECURRENCES WAS: INCORRECT FIXATION OF THE MESH (N = 4), INA DEQUATE SIZE (N = 4), ROAD ACCIDENT (N = 2), AND POSITION OUTSIDE THE ORIGINAL MESH PLACEMENT AREA (N = 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530364 UNKNOWN PROTACK STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN PROTACK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other