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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); Inflammation (1932); Seroma (2069)
Event Date 12/01/2018
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: up100104 is on-going. Findings will be submitted in a follow up adverse event report.
 
Event Description
It was reported that a patient underwent a right side pre-pectoral breast reconstruction with two artia devices ((b)(4)) on (b)(6) 2018. In early (b)(6) 2018 following chemotherapy, patient developed red breast and a late onset infected seroma. The patient was placed on antibiotics and drain placed for 4 weeks which has resolved. Cultures of seroma fluid were negative. The artia devices are still in place. Patient is scheduled for exchange surgery on (b)(6) 2019. This complaint is associated with the first of 2 devices implanted in this patient. Refer to medwatch 1000306051-2018-00162 for the second 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 Key8217838
MDR Text Key132092088
Report Number1000306051-2018-00161
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,Followup,Followup
Report Date 03/19/2019
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 Date01/31/2019
Device Catalogue NumberCM1097
Device Lot NumberUP100104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2017
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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