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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3) MESH, SURGICAL

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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 Date 11/05/2018
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to allergan for evaluation and it is unknown at this time if the strattice was removed. Based on limited information, a relationship between the event and the strattice could not be determined. Due to lack of information, strattice as a contributing factor cannot be ruled out. Lifecell reports the event in abundance of caution. Multiple attempts to obtain additional information are being made; however to date, no further information has been obtained our internal investigation of lot sp100512 includes a review of the reported information, a review of the device history results, and a review of the complaint history records. The review processing history records for lot sp100512 was unremarkable. The lot was aseptically processed and terminally sterilized within process parameters. There were no processing deviations or nonconformance related to the nature of this complaint. There was one unrelated complaint reported to allergan against lot sp100512. As of (b)(6) 2018, of the 478 devices released to finished goods for lot sp100512, 473 have been distributed. Of the 473 distributed, 137 have been reported as implanted. Based on our internal review, lot sp100512 met qc criteria for release. Should additional information be reported, a follow up adverse event report will be submitted.
 
Event Description
Healthcare professional reported left side capsular contracture, baker grade "iii-iv". Device status is unknown.
 
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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 Key8210114
MDR Text Key131890381
Report Number1000306051-2018-00167
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 health professional
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberCON3006
Device Lot NumberSP100512
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 Received12/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2017
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: 01/02/2019 Patient Sequence Number: 1
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