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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 Problems Inflammation (1932); Irritation (1941)
Event Type  Injury  
Manufacturer Narrative
Qa investigation into lot sp100528 resulted in no remarkable findings including 441 devices distributed with no other complaints and no related processing deviations or nonconformances revealed. Lot sp100528 was processed aseptically, terminally sterilized and met all qc release criteria. Device evaluation: acellular collagen graft layers are seen microscopically, consistent with unincorporated collagenous tissue. Many of the cut sections are flanked on one surface by dense eosinophilic fibrotic capsule, separated from the graft collagen by linear infiltrate of lymphocytes with rare polymorphonuclear leukocytes. The appearance suggests some low-grade host reactivity to the graft. Special stains for trichrome (connective tissue) are densely positive, consistent with collagen and not muscular tissue. Fungal (gridley) and bacterial (b&b) stains are negative for organisms. Elastin stain (vvg) shows minimal elastin fibers, consistent with unincorporated porcine collagen.
 
Event Description
It was reported that the patient did well after the first procedure (b)(6) 2017. They had mild inferior descent of the implants and was going to the or for facial surgery under the care of doctor's partner. Doctor opened the vertical incision and performed b inferior capsulorrhaphy with a good aesthetic on table result. The strattice appeared to be will incorporated at that time. Non-incorporated strattice was removed with breast implant on (b)(6) 2018. Patient returned to or on (b)(6) 2019 for further debridement of incorporated strattice and products of degradation of strattice due to u/s evidence of fluid collection which was the sterile, murky appearing breakdown of the residual strattice. Doctor indicated that around this time the patient developed join swelling in their hand, and it looked like raynaud's syndrome. Doctor stated it seems to be that the strattice ¿melted¿ and caused an inflammatory response leading to the loss of breast implant. Affected breast is left. Affected lot is sp100528.
 
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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 Key10025081
MDR Text Key192148291
Report Number1000306051-2020-00023
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 05/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2019
Device Catalogue NumberCON3006
Device Lot NumberSP100528
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2017
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: 05/05/2020 Patient Sequence Number: 1
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