Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Capsular Contracture (1761)
Date of Event 01/09/2020
Type of Reportable Event Serious Injury
Additional 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 or Problem 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3)
Common Device Name
MESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ 08876
MDR Report Key9781396
Report Number1000306051-2020-00011
Device Sequence Number687882
Product Code FTM
UDI-Device Identifier00818410010294
UDI-Public00818410010294
Combination Product (Y/N)N
Initial Reporter StateNV
PMA/510(K) Number
K082176
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date01/31/2021
Device Catalogue NumberCON3006
Device Lot NumberSP200083
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/03/2020
Initial Report FDA Received Date03/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age36 YR
-
-