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U.S. Department of Health and Human Services

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

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TYRX, INC. AIGIS MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TYRX-AAE
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/03/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Concomitant products: 419688 lead, implanted: (b)(6) 2017; dtba2d1 device, implanted: (b)(6) 2015.
 
Event Description
It was reported that following implant of an antibacterial absorbable envelope, a new wavelet was attempted to be obtained and it was noted there was difficulty obtaining the wavelet, as the can to rvcoil signal was low in amplitude for the competitor right ventricular (rv) lead. It was suspected the difficulty in collecting the template was due to the envelope. The range of the amplitude was changed and a wavelet was obtained. The envelope remains in use. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameAIGIS
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TYRX, INC.
1 deer park dr.
suites g, e
monmouth jct,nj MN 08852
Manufacturer (Section G)
TYRX, INC.
1 deer park dr.
suites g, e
monmouth jct,nj MN 08852
Manufacturer Contact
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key6780828
MDR Text Key137421997
Report Number2182208-2017-01184
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTYRX-AAE
Device Catalogue NumberTYRX-AAE
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 Received02/15/2019
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

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