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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 Product Quality Problem (1506)
Patient Problem Erosion (1750)
Event Date 02/17/2017
Event Type  Injury  
Manufacturer Narrative
Product analysis determined to not be required. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Concomitant medical products: 5071-35 lead, implanted: (b)(6) 2010; 6945-65 lead, implanted: (b)(6) 1998. 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.
 
Event Description
It was reported the antibacterial envelope did not absorb and caused erosion through the skin when the device moved laterally. It was also reported the device migrated and eroded through the skin. It was noted this was due to the patient losing a lot of weight. The envelope was removed and the device was re-positioned back into the pocket. 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 Key6467523
MDR Text Key104272784
Report Number3005619263-2017-00013
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,Followup
Report Date 02/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2016
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot Number16A20687
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/20/2016
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: 04/06/2017 Patient Sequence Number: 1
Treatment
DTBB1D1 ICD
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