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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL SMALL CURVED SHAPE FOR STRATTICE, BPS (CONTOUR 1) MESH, SURGICAL

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LIFECELL SMALL CURVED SHAPE FOR STRATTICE, BPS (CONTOUR 1) MESH, SURGICAL Back to Search Results
Catalog Number CON1006
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907)
Event Type  Injury  
Manufacturer Narrative
Device has not been returned as it remains implanted. Internal investigation into lot number sp200131 is currently ongoing. Further information regarding this case has been requested, to date, no further information has been received. Relationship between the strattice and the event could not be determined. No further actions are required as a nonconformance could not be confirmed.
 
Event Description
Healthcare professional reported patient had blister like sores filled with puss within a couple days/week of her surgery. Patient initially thought it was a bug bit but then spread to both breasts. Patient went to infectious disease and was put on antibiotics but issue did not resolve. Healthcare professional took her back to the operating room on (b)(6) 2020 and did a pocket exam. Strattice was well incorporated and no sign of fluid around the implant. Patient saw a dermatologist today and the dermatologist feels it may be an ¿allergy to adm¿. A medical exam was performed by patient's primary provider. Chief complaints noted to be: "lichen sclerosus et atrophicus" (lsa), and "granulomatous dermatitis". "strattice mesh suspected to be the stimulus for the granulomatous reaction since the two repeated pan tissue cultures have been negative. Also, lichen scierosus et atrophicus has ecm1 autoantibody (extracellular matrix 1 is the autoantigen). " the lsa is being treated with tacolimus. 1% topical ointment twice daily. The granulomatous dermatitis is being treated with methotrexate intralesional injection, and doxycycline. "two repeated pan-tissue cultures still no growth to date". "caution for occult infection". "granulomatous dermatitis improved with methotrexate injections. Strattice is the implicated stimulus for the granulomatous reaction given its dermal matrix mesh - the autoantigen of lichen sclerosus et atrophicus is extracellular matrix 1 protein, which is a component in the dermal matrix. Infections cause was ruled out after 2 repeated pan-tissue cultures have been negative. " "patient and patient's husband were advised to ask the surgeon to remove the strattice acellular dermal matrix from breasts. ".
 
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Brand NameSMALL CURVED SHAPE FOR STRATTICE, BPS (CONTOUR 1)
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
brent livingstone
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key10524356
MDR Text Key206759730
Report Number1000306051-2020-00048
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,Followup
Report Date 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2021
Device Catalogue NumberCON1006
Device Lot NumberSP200131
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 Received08/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2020
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: 09/11/2020 Patient Sequence Number: 1
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