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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 05/01/2014
Event Type  malfunction  
Event Description
It was reported that the envelope was implanted after use before 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.(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 DISEASE MGMT
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
nashoane fulwood-kelley
8200 coral sea st ne
mounds view, MN 55112
7635260583
MDR Report Key3994644
MDR Text Key4824238
Report Number3005619263-2014-00007
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
Reporter Occupation Health Professional
Type of Report Initial
Report Date 05/15/2014
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 Health Professional
Device Expiration Date04/28/2014
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/15/2014
Initial Date FDA Received08/08/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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