• 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 C-QUR V-PATCH 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 C-QUR V-PATCH MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31200
Event Date 04/01/2015
Event Type  Injury  
Event Description

Open umbilical hernia without issue. In (b)(6) patient began complaining of "severe pain" and a purple/blue discoloration on and around her incision/scar.

 
Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

 
Manufacturer Narrative

The lot history and sterilization records were reviewed. All records were found to be complete and showed that the product was manufactured to specifications. The following testing was required, and performed for this product: analysis of fish oil, fourier-transform infrared spectrophotometry (ftir) testing for coated mesh panels, suture retention and ball burst testing of bare mesh panels, and stitch strength testing. The analysis of fish oil showed that all requirements for chemical composition met acceptance criteria. The manufacturing records, inspection records, and sterilization records showed no non conformances or deviations. Based on the lot history review, there are no indications that the product was responsible for the incident reported. Clinical opinion: refractory chronic pain is characterized by pain that persists despite treatment and for longer than expected. Causes are varied and pain can occur anywhere in the body. Complications may occur due to a technical error, inadequate fixation and/or inadequate overlap which will cause separation of the mesh from the abdominal wall thereby increasing the possibility of infection, perforation, seroma, adhesions and pain. The instructions for use state complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection or mechanical disruption of the tissue and/or mesh material and possible adhesions when placed in direct contact with the viscera (intestines).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameC-QUR V-PATCH MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH 03051
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH
Manufacturer Contact
theresa morin
5 wentworth drive
hudson , NH 03051
6038645237
MDR Report Key4849867
Report Number1219977-2015-00172
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/12/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2017
Device MODEL Number31200
Device Catalogue Number31200
Device LOT Number210643
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/25/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/16/2015 Patient Sequence Number: 1
-
-