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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. AIGIS MESH, SURGICAL, POLYMERIC

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MEDTRONIC, INC. AIGIS MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TYRX-AE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 07/14/2018
Event Type  Injury  
Manufacturer Narrative
This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. Of note, multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers. The baseline gender/age characteristics is female/47 years old. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: evaluation of antibiotic-impregnated mesh in preventing the recurrence of capsular contracture. Aesthetic surgery journal. 2019. 39(5); 509¿515. Doi: 10. 1093/asj/sjy171. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was reviewed that contained information regarding this antibacterial absorbable envelope. The article reports a patient who developed a small hematoma of the right breast with the use of an antibacterial absorbable envelope on post operative day one, which required surgical evacuation. No further patient complications have been reported as a result of this event. Further follow up did not yet yield any additional information.
 
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Brand NameAIGIS
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key12233690
MDR Text Key263821270
Report Number2182208-2021-02985
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063091
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTYRX-AE
Device Catalogue NumberTYRX-AE
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 Received07/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 07/27/2021 Patient Sequence Number: 1
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