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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 CMRM6122CA
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 09/13/2018
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 manufactured date and the expiration date on the packaging of the absorbable antibacterial envelope were incorrect because the dates were switched with one another. The products were not used. There was no patient involvement.
 
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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 Key7876946
MDR Text Key120708017
Report Number3005619263-2018-00078
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K130943
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model NumberCMRM6122CA
Device Catalogue NumberCMRM6122CA
Device Lot Number18F18051
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 Received09/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/11/2018
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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