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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE MESH, SURGICAL

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LIFECELL UNKNOWN STRATTICE MESH, SURGICAL Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Necrosis (1971)
Event Type  Injury  
Manufacturer Narrative
Corresponding author. This literature review is being reported as an individual event type as serious injury due to the medical and/or surgical intervention to treat the complications of infection and skin necrosis. Multiple attempts are being made to gather additional patient and procedure specific information including lot numbers and device dispositions. To date, the lot numbers associated with these events remain unknown; therefore an internal investigation into the device history records could not be performed. No devices were returned to lifecell for evaluation. A relationship to the strattice could not be determined. If additional information is received, a follow up report will be submitted. No further actions are required as a nonconformance could not be confirmed.
 
Event Description
During a literature review, an article titled "laser-assisted indocyanine green angiography in implant-based immediate breast reconstruction: a retrospective study," was identified that reported a retrospective review performed at the department of plastic and breast surgery at aarhus university hospital in denmark on all patients who underwent implant-based skin-sparing immediate breast reconstruction with strattice from march 2012 to october 2015. A total of 92 patients undergoing 128 breasts reconstructions were included in the study. An evaluation of complications before and after the implementation of la-icga was performed. Complications for both study groups included necrosis requiring revision surgery, clinical necrosis treated solely with conservative treatment in outpatient clinic, infection requiring additional antibiotics, hematoma, seroma. Implant exchange and reconstructive failure (defined as removal of the implant or expander) were also reported.
 
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Brand NameUNKNOWN STRATTICE
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 Key8094496
MDR Text Key128042807
Report Number1000306051-2018-00146
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
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 Received10/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/21/2018 Patient Sequence Number: 1
Treatment
NO INFORMATION
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