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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC

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MEDTRONIC, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number CMRM6122INT
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2019
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 antibacterial absorbable envelope was implanted after the indicated use before date (ubd). The antibacterial absorbable envelope remains in use. No patient complications have been reported as a result of this event.
 
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Brand NameTYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key8905579
MDR Text Key154731641
Report Number2182208-2019-01510
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
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 08/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model NumberCMRM6122INT
Device Catalogue NumberCMRM6122INT
Device Lot NumberR113878R20
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 Received08/14/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/04/2019
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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