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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 Device Expiration Issue (1216)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/03/2014
Event Type  malfunction  
Event Description
It was reported that the envelope was implanted three days after the expiration date.The envelope remains in use.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant product: 2 - 1888tc st.Jude leads, implanted: (b)(6) 2008.(b)(4).
 
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Brand Name
AIGIS-R LARGE
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TYRX, INC.
1 deer park dr.
suites g, e
monmouth jct NJ 08852
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key4319125
MDR Text Key21173415
Report Number3005619263-2014-00014
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/31/2014
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot Number14F25473
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/23/2015
Initial Date FDA Received12/10/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/09/2015
Date Device Manufactured06/25/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
C4TR01, IPG, 6725, ADAPTOR
Patient Age00085 YR
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