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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL UNKNOWN ARTIA MESH, SURGICAL

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LIFECELL UNKNOWN ARTIA MESH, SURGICAL Back to Search Results
Catalog Number UNK ARTIA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Unspecified Infection (1930); Seroma (2069)
Event Date 09/15/2018
Event Type  Injury  
Manufacturer Narrative
Conclusion: this event is being reported for the medical intervention to treat the late onset infected seroma. The report of patchy areas of incorporation at the time of exchange is an incidental finding. The device remains implanted and has not been returned for evaluation. Based on limited information, including no identification of the relevant lot number, a relationship between the event and the artia could not be determined. Due to lack of information, artia as a contributing factor cannot be ruled out. Multiple attempts to obtain additional information are being made, including the identification of the lot number. To date, the lot number associated with this event remains unknown; therefore an internal investigation into the device history records could not be performed. Should additional information be reported, a follow up adverse event report will be submitted. No further actions are required as a nonconformance could not be confirmed.
 
Event Description
It was reported that a patient underwent a right side pre-pectoral unilateral reconstruction with two artia devices on (b)(6) 2017. On (b)(6) 2017, patient underwent exchange where the artia was noted intra-op to have areas of patchy incorporation. On (b)(6) 2018, patient underwent a right nipple-areola reconstruction. The following month on (b)(6) 2018, patient developed red breast and a late onset infected seroma. Patient was placed on antibiotics and drain placed for 4 weeks and seroma resolved. Cultures of seroma fluid were negative. Patient is currently ok. The artia devices are still in place. This complaint is associated with the second of 2 devices implanted in this patient. Refer to medwatch 1000306051-2018-00156 for the first device implanted in this patient.
 
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Brand NameUNKNOWN ARTIA
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 Key8217781
MDR Text Key132091498
Report Number1000306051-2018-00158
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 01/07/2019
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 Catalogue NumberUNK ARTIA
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 Received01/07/2019
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: 01/04/2019 Patient Sequence Number: 1
Treatment
NO INFORMATION
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