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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR MEDIUM MESH, SURGICAL

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LIFECELL ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR MEDIUM MESH, SURGICAL Back to Search Results
Catalog Number CM1097
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Unspecified Infection (1930); Seroma (2069)
Event Date 10/15/2018
Event Type  Injury  
Manufacturer Narrative
Conclusion: this event is being reported for the medical intervention to treat the late onset infected seroma. The device remains implanted and has not been returned for evaluation. Lot number information was received on 03/jan/2019; therefore a review of the device history records for lot up100096 is on-going. Findings will be submitted in a follow up adverse event report.
 
Event Description
It was reported that a patient underwent a bilateral pre-pectoral breast reconstruction with artia (l: (b)(4)) on (b)(6) 2017. On (b)(6) 2018, patient underwent bilateral exchange for implants and the artia appeared fine intraoperatively. In mid-(b)(6) 2018, the patient developed left side red breast and late onset infected seroma. Patient was placed on antibiotics and drain placed for 4 weeks and has resolved. Cultures of seroma fluid were negative. The artia devices are still in place. This complaint is associated with the second of 2 devices implanted on the left side in this patient. Refer to medwatch 1000306051-2018-00159 for the first device implanted in this patient.
 
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Brand NameARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR MEDIUM
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 Key8217816
MDR Text Key132092072
Report Number1000306051-2018-00160
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K142326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2018
Device Catalogue NumberCM1097
Device Lot NumberUP100096
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 Received01/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2017
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: 01/04/2019 Patient Sequence Number: 1
Treatment
NO INFORMATION
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