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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2) MESH, SURGICAL

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LIFECELL MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2) MESH, SURGICAL Back to Search Results
Catalog Number CON2006
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Capsular Contracture (1761); No Information (3190)
Event Date 03/15/2018
Event Type  Injury  
Manufacturer Narrative
Conclusion: based on limited information, including no identification of the relevant lot number, a relationship between the event and strattice could not be determined. Due to lack of information, strattice as a contributing factor cannot be ruled out. Lifecell reports the event in an abundance of caution. Attempts to obtain additional information are being made, including identification of the lot number. Should additional information be reported, a follow up adverse event report will be submitted; otherwise this investigation is concluded.
 
Event Description
This report is associated with the strattice mesh placement on the left side. Please refer to mdr 1000306051-2018-00075 for the event associated with the right side. It was reported that the female patient had bilateral breast augmentation revision surgery (b)(6) 2015 with strattice. On (b)(6) 2018, the patient had another augmentation revision on the left side due to an unspecified failure of the strattice.
 
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Brand NameMEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2)
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 Key7570729
MDR Text Key110127891
Report Number1000306051-2018-00074
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2016
Device Catalogue NumberCON2006
Device Lot NumberSP100193
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 Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2014
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: 06/05/2018 Patient Sequence Number: 1
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