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

MAUDE Adverse Event Report: LIFECELL LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3) 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 LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3) MESH, SURGICAL Back to Search Results
Catalog Number CON3006
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Capsular Contracture (1761)
Event Type  Injury  
Manufacturer Narrative
Based on the information reported, including no identification of the relevant lot number, a relationship between the event and strattice cannot be determined. Strattice as a contributing factor cannot be ruled out. Multiple attempts were made to gather additional information; however to date, no further information has been obtained. The device was not returned for evaluation as it was discarded and the lot number remains unknown; therefore internal investigation into the event could not be performed. If additional information is reported, a follow up adverse event report will be submitted. No further actions are required as a nonconformance could not be confirmed.
 
Event Description
It was reported that a patient was implanted with strattice bps on (b)(6) 2019. In the months following surgery, the patient experienced recurrent capsular contracture on the right breast. Explant of the device occurred on (b)(6) 2019. The device was discarded and is not available for return.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3)
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 Key8612667
MDR Text Key145137929
Report Number1000306051-2019-00071
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K082176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCON3006
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/15/2019 Patient Sequence Number: 1
-
-