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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE MESH, SURGICAL

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LIFECELL UNKNOWN STRATTICE MESH, SURGICAL Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Capsular Contracture (1761)
Event Date 02/15/2019
Event Type  Injury  
Manufacturer Narrative
Article citation: wilson rl, kirwan cc, o'donoghue jm, linforth ra, johnson rk, harvey jr. The long-term outcomes of the browse multicentre cohort study comparing strattice¿-assisted implant based reconstruction and submuscular reconstruction [abstract]. In: proceedings of the 2018 san antonio breast cancer symposium; 2018 dec 4-8; san antonio, tx. Philadelphia (pa): aacr; cancer res 2019;79(4 suppl):abstract nr p5-16-03. The event of capsular contracture baker grade unknown is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. The reason for reoperation: capsular contracture baker grade unknown. Further information from the reporter regarding event, product, or patient details will not be requested as contact information was not provided. No additional information is available at this time. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Through journal article ¿the long-term outcomes of the browse multicentre cohort study comparing strattice¿-assisted implant based reconstruction and submuscular reconstruction,¿ the event of patients in strattice group experienced capsular contracture, baker grade unknown, and 7% of those patients underwent surgical intervention was reported.
 
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Brand NameUNKNOWN STRATTICE
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 Key8731588
MDR Text Key149100815
Report Number1000306051-2019-00082
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
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 Received05/10/2019
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: 06/25/2019 Patient Sequence Number: 1
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