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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 Unspecified Infection (1930); Necrosis (1971); Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
Article citation: 'implant-based breast reconstruction with artia tissue matrix' b. Fakim, l. Highton and a. Gandhi et al. , implant-based breast reconstruction with artia tm tissue matrix, journal of plastic, reconstructive & aesthetic surgery, https://doi. Org/10. 1016/j. Bjps. 2019. 05. 024. The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. The reason for reoperation: seroma, infection, necrosis. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Article reports 6 breasts developing seromas requiring aspiration, 1 breast developing a haematoma and 2 implant losses due to necrosis and infection. It is unknown if the device remains implanted.
 
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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 Key8821162
MDR Text Key152025230
Report Number1000306051-2019-00095
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K142326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2019
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 Received06/24/2019
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: 07/24/2019 Patient Sequence Number: 1
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