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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 NMR6133
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 10/23/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient developed a staphylococcus infection after application of the absorb-able antibacterial envelope. The associated products were removed. No further patient complications have been reported as a result of this event.
 
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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
Manufacturer (Section G)
TYRX, INC.
1 deer park dr
suites g, e
monmouth jct NJ
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6164034
MDR Text Key104282571
Report Number3005619263-2016-00052
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150291
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 10/24/2016
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 Date09/30/2016
Device Model NumberNMR6133
Device Catalogue NumberNMR6133
Device Lot Number16H15753
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 Received10/24/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/15/2016
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
97714 IPG, 977A260 LEAD, 977A260 LEAD
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