• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION MAQUET GETINGE GROUP C-QUR MESH O3FA COATED POLYPPROPYLENE MESH MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRIUM MEDICAL CORPORATION MAQUET GETINGE GROUP C-QUR MESH O3FA COATED POLYPPROPYLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31537
Device Problems Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)
Patient Problem No Code Available (3191)
Event Date 12/04/2018
Event Type  Malfunction  
Event Description

This mesh was identified as a problem as a retained surgical item. The mesh was trimmed and the clear, colorless, shiny portion of the sleeve was no longer distinguishable from the coated surface of the mesh. The absence of color or markings on the sleeve allowed the portion of the sleeve still clinging to the mesh to be implanted without detection. The pt was already in recovery by the error was realized by a surgical tech. The pt had to be re-intubated and go back under anesthesia and re-opened to obtain the mesh backing. We would like to recommend that a print or colored markings be added to the sleeve.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAQUET GETINGE GROUP C-QUR MESH O3FA COATED POLYPPROPYLENE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
MDR Report Key8536069
MDR Text Key142879897
Report NumberMW5086035
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number31537
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/19/2019 Patient Sequence Number: 1
-
-