BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO

    MDR report key: 10599137 · Received September 29, 2020

    Report

    Report Number
    1219930-2020-04018
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    December 28, 2019
    Report Date
    October 30, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM 2008 TO 2018, POSTOPERATIVE FROM MIDLINE LAPAROTOMY WITH BOWEL RESECTION, 5 PATIENTS HAD INFECTION, 1 PATIENT HAD MESH REMOVAL, 8 PATIENTS HAD SEROMA IN WHICH 4 WERE SUBSEQUENTLY DRAINED, 8 PATIENTS HAD PERSISTING PAIN AND 3 PATIENTS HAD HEMATOMA IN WHICH 2 REQUIRED SURGERY. FOR THE PATIENTS WHO UNDERWENT ILEOSTOMY REVERSAL, 3 PATIENTS HAD INFECTION, 1 PATIENT HAD SEROMA WHICH WAS SUBSEQUENTLY DRAINED, 4 PATIENTS HAD PERSISTING PAIN AND 1 PATIENT HAD HEMATOMA WHICH REQUIRED SURGERY. THESE COMPLICATIONS WERE NOT RELATED TO THE DEVICE REPORTED.

    Additional Manufacturer Narrative · 1

    TITLE: ABDOMINAL WALL CLOSURE WITH PROPHYLACTIC MESH IN COLORECTAL OPERATIONS SOURCE: ANZ J SURG 90 (2020) 564¿568 PUBLISHED: 28 DECEMBER 2019. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM 2008 TO 2018, POSTOPERATIVE FROM MIDLINE LAPAROTOMY WITH BOWEL RESECTION, 5 PATIENTS HAD INFECTION, 1 PATIENT HAD MESH REMOVAL, 8 PATIENTS HAD SEROMA IN WHICH 4 WERE SUBSEQUENTLY DRAINED, 8 PATIENTS HAD PERSISTING PAIN AND 3 PATIENTS HAD HEMATOMA IN WHICH 2 REQUIRED SURGERY. FOR THE PATIENTS WHO UNDERWENT ILEOSTOMY REVERSAL, 3 PATIENTS HAD INFECTION, 1 PATIENT HAD SEROMA WHICH WAS SUBSEQUENTLY DRAINED, 4 PATIENTS HAD PERSISTING PAIN AND 1 PATIENT HAD HEMATOMA WHICH REQUIRED SURGERY. ARTICLE: JEAN WONG, JULIA JONES, 2019, SAIKRISHNA ANANTHAPADMANABHAN AND ALAN P. MEAGHER, ABDOMINAL WALL CLOSURE WITH PROPHYLACTIC MESH IN COLORECTAL OPERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064683 SURGIPRO MESH, SURGICAL, POLYMERIC FTL COVIDIEN LP LLC NORTH HAVEN UNKNOWN SURGIPRO MESH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention