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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 TYRX-AAE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 09/23/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the senior author which indicated the antibacterial envelope was not used in any of the patients mentioned in the article. There is no information in this article to suggest that the use of the envelope contributed to any of these infections.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
This information is based entirely on journal literature. Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device lot numbers. The mean age of the patients was sixty-four (64) years of age and 63. 7% were male. Since no device id was provided, it is unknown if this event has been previously reported. Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: ¿complication rates, lengths of stay, and readmission rates in ¿awake¿ and ¿asleep¿ deep brain simulation. ¿ journal of neurosurgery. Published online september 23, 2016; doi: 10. 3171/2016. 6. Jns152946.
 
Event Description
A journal article was reviewed which contained information regarding implantable absorbable antibacterial envelopes. Multiple patients were noted in the article; however, a one to one correlation could not be made with device lot numbers. There were three patients who experienced postoperative infections. The systems and envelopes were explanted. Further follow up did not yet yield any additional information. 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 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 Key6164077
MDR Text Key104272441
Report Number3005619263-2016-00053
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/11/2016
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 Model NumberTYRX-AAE
Device Catalogue NumberTYRX-AAE
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 Received06/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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
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