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U.S. Department of Health and Human Services

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

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TYRX, INC. AIGIS-R LARGE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number CMRM6133
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 08/09/2016
Event Type  Injury  
Event Description
It was reported that after implant, upon discharge, it was noted that the patient had a small hematoma at the implant site. The physician decided to monitor the site. After one week, there was no change in size/appearance of the hematoma. Three weeks post implant the patient was admitted back to hospital after noticing an increase in size/change in appearance. The physician removed the absorbable envelope from around the device and revised the pocket. No new absorbable envelope was implanted and the pocket was closed. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameAIGIS-R LARGE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TYRX, INC.
1 deer park dr.
suites g, e
monmouth jct NJ 08852
Manufacturer (Section G)
TYRX, INC.
1 deer park dr.
suites g, e
monmouth jct NJ 08852
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6161771
MDR Text Key62109647
Report Number3005619263-2016-00049
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K130943
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
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 Received09/01/2016
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: 12/09/2016 Patient Sequence Number: 1
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