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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 NMRM6133
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/07/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Investigation conclusion: lot# 16h15753 - the particle was located on the interior surface of the envelope. The particle had a dark and glassy appearance in the optical images. The particle was about 1mm in length. The sample was sent to the lab to determine the origin of the foreign matter. The unknown residue was thoroughly characterized by infrared spectroscopy and tof-sims. The results show the unknown material from the field return is similar to material from the spraying, and is composed of a mixture of thk afa grease and api coating (tyrosine polymer, minocycline and rifampin). 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 that during the implant procedure the absorbable envelope was opened and found to have a visible anomaly on the envelope, a black spec. The envelope was inspected before going to the sterile field by the implanting physician who determined it should be discarded. Another envelope was implanted. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
The device envelope was returned and analyzed. Analysis of the returned product indicated an issue with the device envelope appearance. There was a particle located on the interior surface of the envelope. The particle had a dark and glassy appearance in the optical images. The particle was about 1mm in length. The sample was sent to the lab to determine the origin of the foreign matter. The unknown residue was thoroughly characterized by infrared spectroscopy and time-of-flight secondary ion mass spectrometry (tof-sims). The results suggest the unknown material from the field return is similar to material from the spraying/drying oven, and is composed of a mixture of thk afa grease and active pharmaceutical ingredient (api) coating. 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.
 
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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 Key6164742
MDR Text Key104288232
Report Number3005619263-2016-00055
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,Followup
Report Date 09/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2016
Device Model NumberNMRM6133
Device Catalogue NumberNMRM6133
Device Lot Number16H15753
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2016
Was Device Evaluated by Manufacturer? Yes
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

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