BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MESH

    MDR report key: 12045604 · Received June 22, 2021

    Report

    Report Number
    3011175548-2021-00692
    Event Type
    Injury
    Date Received
    June 22, 2021
    Report Date
    October 17, 2022
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE REVIEWED: WANG ET AL. 2021. LARGE ABDOMINAL HERNIA REPAIR WITH CLOSED INCISION NEGATIVE PRESSURE THERAPY: A CASE SERIES. J WOUND CARE; 30(3):192-196. THIS COMPLAINT IS BASED ON INFORMATION FOUND WITHIN AN ARTICLE/LITERATURE REVIEW. THERE WAS NO PRODUCT THAT WAS AVAILABLE FOR EVALUATION, THEREFORE A DEVICE EVALUATION COULD NOT BE CONDUCTED AND THE COMPLAINT CANNOT BE CONFIRMED. THE AUTHOR OF THE ARTICLE DID NOT REPORT ANY MAJOR ADVERSE PATIENT EFFECTS AS RESULT OF THIS EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE DEVICE PRODUCT PART NUMBER AND LOT NUMBER WAS NOT PROVIDED WITHIN THE ARTICLE. ATTEMPTS TO OBTAIN THE DEVICE LOT INFORMATION WAS CONDUCTED BUT UNSUCCESSFUL. THE HAZARDOUS SITUATION/HARM IS ADDRESSED IN THE RISK FILE AND IS OPERATING WITHIN ITS RISK PROFILE. THERE WAS NO EVIDENCE WITHIN THE ARTICLE THAT THE DEVICE WAS THE CAUSE OF THE REPORTED EVENT. THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY AN ADVERSE TREND, THEREFORE NO ESCALATION TO CAPA PROCESS IS REQUIRED. CONCLUSION: ALTHOUGH SURGICAL SITE INFECTIONS WERE COMMON AFTER LARGE INCISIONAL HERNIA REPAIR, WITH AN INCIDENCE IN THIS PATIENT POPULATION OF 43%, 62% IN CONTROL GROUP COMPARED WITH 32% IN THE CINPT TREATMENT GROUP, HOWEVER CONSIDERING THE DESIGN OF THE STUDY, NON-SIGNIFICANT REDUCTIONS IN WOUND INFECTION, SEROMA AND WOUND DEHISCENCE AND THE FACT THAT THIS STUDY DEMONSTRATED A STATISTICALLY SIGNIFICANT DECREASED RATE OF RETURN TO OR FOR HERNIA RECURRENCE, ONE CAN INFER THAT THE ATRIUM C-QUR¿ POLYPROPYLENE MESH PERFORMED AS EXPECTED. THE AUTHORS DID NOT ATTRIBUTE OCCURRED COMPLICATION TO ANY PARTICULAR TYPE OF MESH.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ARTICLE RECEIVED: WANG, E. E. (2021). LARGE ABDOMINAL HERNIA REPAIR WITH CLOSED INCISION NEGATIVE PRESSURE THERAPY: A CASE SERIES. JOURNAL OF WOUND CARE, 192-196. PURPOSE: THIS STUDY ASSESSES THE WOUND OUTCOMES FOR HERNIA REPAIR PATIENTS RECEIVING CLOSED INCISION NEGATIVE PRESSURE THERAPY (CINPT). METHOD: A SIX-YEAR RETROSPECTIVE CASE SERIES OF PATIENTS WHO HAD UNDERGONE LARGE ABDOMINAL INCISIONAL HERNIA REPAIR WOUNDS TREATED WITH CINPT WAS CONDUCTED. CONCLUSION: CINPT, WHEN USED AFTER LARGE ABDOMINAL INCISIONAL HERNIA REPAIR, MAY HELP IN THE PREVENTION OF WOUND COMPLICATIONS. PER THE ARTICLE ADVERSE EVENTS INCLUDED: SURGICAL SITE INFECTION, SEROMA, DEHISCENCE AND RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939519 C-QUR MESH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNKNOWN.