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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TYRX, INC. AIGIS-R MEDIUM MESH, SURGICAL, POLYMERIC

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TYRX, INC. AIGIS-R MEDIUM MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number CMRM6122
Device Problem Shelf Life Exceeded (1567)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the absorbable antibacterial envelope was implanted after the use before date. The envelope remains implanted. No patient complications have been reported as a result of this event.
 
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Brand NameAIGIS-R MEDIUM
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 Key7256443
MDR Text Key99914496
Report Number3005619263-2018-00020
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
Report Date 02/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2017
Device Model NumberCMRM6122
Device Catalogue NumberCMRM6122
Device Lot Number17J21172
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 Received12/04/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/21/2017
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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