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

MAUDE Adverse Event Report: LIFECELL ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR LARGE MESH, SURGICAL

  • 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
 

LIFECELL ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR LARGE MESH, SURGICAL Back to Search Results
Catalog Number CL1097
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Capsular Contracture (1761)
Event Type  Injury  
Manufacturer Narrative
Our investigation of lot up100097 includes: manufacturing review: review of information as reported. Review of the device history records and complaint history records associated with lot sp100493. Results of review: review of the processing history records for lot up100097 is as follow: the lot was aseptically processed, terminally sterilized, and met qc release criteria. 87 devices were released to finished goods. As of (b)(6) 2019, three similar complaints have been reported against lot up100097. As of (b)(6) 2019, of the 87 devices released to finished goods for lot up100097, 46 have been distributed. Of the 46 distributed, 27 have been reported as implanted. Conclusion: qa investigation into lot up100097 resulted in no remarkable findings including 46 devices distributed with three similar complaints reported against the lot and no deviations or nonconformances revealed during processing. Lot up100097 was terminally sterilized and met all qc release criteria including mechanical testing.
 
Event Description
It was reported that a doctor implanted artia back in (b)(6) of 2017. They had used two pieces of artia bilaterally on a breast revision patient. Patient has now presented with bilateral nodules that have formed along their imf and lateral folds. Patient has recurrent capsular contracture baker grade iii on both sides. Doctor plans on removing the artia on (b)(6) 2019. Device with lot number up100097 was affected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR LARGE
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer (Section G)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471100
MDR Report Key9118353
MDR Text Key165579678
Report Number1000306051-2019-00111
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K142326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2018
Device Catalogue NumberCL1097
Device Lot NumberUP100097
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2017
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: 09/25/2019 Patient Sequence Number: 1
-
-