• 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, 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, SURGICAL, POLYMERIC Back to Search Results
Model Number 31202
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Surgeon reported that the product was opened and soaked, then touched the patient when it came apart. Surgeon set the mesh aside and used another mesh.
 
Manufacturer Narrative
(b)(4). Upon completion of the investigation into this event a follow up report will be submitted.
 
Manufacturer Narrative
Investigation: upon investigation of the returned mesh sample, it was noticed that a section of stitching around the perimeter of the patch appeared to be absent. The mesh did not look mishandled or physically adulterated (cut/torn) in any way. This defect is referred to internally as "missing stitches" where there is a void in the stitch pattern. "missing stitches" is a sewing defect that can occur during setup of each sewn piece and is 100% visually inspected for in manufacturing. The setup is repeated prior to each v-patch sub-assembly being sewn, and an error in the setup of one does not relate to an error in setup of a previous or subsequent sub-assembly. This is likely an isolated incident that was not identified during 100% visual inspection following the sewing process. A lot history and sterilization records review was conducted for the lot of v-patch associated with this complaint. There were no deviations or non-conformances noted with the stitching or construction of the v-patch. The product was documented to have met all lot release criteria, including 100% visual inspection of stitching, prior to lot release. A review of our complaints show that there are no other reports of this type of defect.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameC-QUR V-PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH
Manufacturer Contact
theresa morin
5 wentworth drive
hudson, NH 03051
6038645237
MDR Report Key4953313
MDR Text Key15915426
Report Number1219977-2015-00207
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080688
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative,company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Model Number31202
Device Catalogue Number31202
Device Lot Number217489
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2014
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: 07/30/2015 Patient Sequence Number: 1
-
-