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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 Problems Cellulitis (1768); Unspecified Infection (1930); Pain (1994)
Event Date 11/11/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Concomitant product: 694265 lead implanted: (b)(6) 1997.
 
Event Description
It was reported the patient presented to the clinic approximately six weeks post implant with concerns of pus located at the device site. In the pocket area there was pain, redness, and purulent drainage. The infection was noted to be limited to cellulitis and the organism responsible was staphylococcus aureus. The patient was treated with antibiotics and recovered. The device remains in use. The patient is a participant in the (b)(6) trial. No further patient complications have been reported as a result of this event.
 
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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 Key6163947
MDR Text Key104282747
Report Number3005619263-2016-00051
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130943
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/18/2016
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? No
Device Operator
Device Expiration Date10/31/2015
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot Number15H21632
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 Received10/18/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/08/2015
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
Treatment
DDBB1D1 ICD, 5076-52 LEAD
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