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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TYRX, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE; MESH, SURGICAL, POLYMERIC
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TYRX, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number CMRM6133
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/19/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 383069 lead, implanted: (b)(6) 2020; 693565 lead, implanted: (b)(6) 2011.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) system that was implanted with an antibacterial absorbable envelope was explanted due to a pocket infection.Cultures were taken.No further 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)
TYRX, INC.
1 deer park dr.
suites g, e
monmouth jct NJ 08852
MDR Report Key10250234
Report Number3005619263-2020-00006
Device Sequence Number485618
Product Code FTL
UDI-Device Identifier00763000101619
UDI-Public00763000101619
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K130943
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date02/29/2020
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot NumberR124080
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/19/2020
Initial Report FDA Received Date07/09/2020
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
DTMA1D1 CRTD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age85 YR
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