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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICE CREEK MFG TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE; MESH, SURGICAL, POLYMERIC
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RICE CREEK MFG 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 11/14/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that approximately seven weeks post implant the absorbable antibacterial envelope was removed with the implantable cardioverter defibrillator (icd) system due to an infection.The icd system was not replaced.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)
RICE CREEK MFG
7000 central ave ne
fridley MN 55432
MDR Report Key9570048
Report Number6000030-2020-00002
Device Sequence Number13567707
Product Code FTL
UDI-Device Identifier00763000101619
UDI-Public00763000101619
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
K130943
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/09/2020
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 Date11/30/2019
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot NumberR119259
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/07/2020
Initial Report FDA Received Date01/09/2020
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
6935M55 LEAD, 5076-45 LEAD, DDMB1D4 ICD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age49 YR
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