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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 CMRM6133
Medical Device Problem Code Human-Device Interface Problem (2949)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/16/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that a antibacterial absorbable envelope was implanted that was post its indicated use before date (ubd).The device remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key9125833
Report Number2182208-2019-01746
Device Sequence Number19407637
Product Code FTL
UDI-Device Identifier00763000101619
UDI-Public00763000101619
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K130943
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date07/31/2019
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot NumberR114531
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/16/2019
Initial Report FDA Received Date09/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
W1SR01, IPG / 407658, LEAD
Patient Age77 YR
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