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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 01/09/2020
Event Type  Injury  
Manufacturer Narrative
The strattice will not be returned as it was discarded. Qa investigation into lot sp200083 resulted in no remarkable findings including 414 devices distributed with no similar complaints against the lot and no processing deviations or nonconformances related to the nature of this complaint. Lot sp200083 was terminally sterilized and met all qc release criteria.
 
Event Description
It was reported that the patient experienced a recurrence of capsular contracture with baker grade iii. The strattice was placed on (b)(6) 2020 and removed on (b)(6) 2020. Lot sp200083 was affected and discarded after surgery.
 
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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
9089471470
MDR Report Key9781396
MDR Text Key188139187
Report Number1000306051-2020-00011
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
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Catalogue NumberCON3006
Device Lot NumberSP200083
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 Received02/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2019
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: 03/03/2020 Patient Sequence Number: 1
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