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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 CMRM6122
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/19/2018
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 the patient experienced an infection approximately two months after the implant of an implantable pulse generator (ipg) with an antibacterial absorbable envelope.The implantable pulse generator (ipg) system was explanted.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 Key8680568
Report Number6000030-2019-00047
Device Sequence Number2016526
Product Code FTL
UDI-Device Identifier00643169935891
UDI-Public00643169935891
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K130943
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/07/2019
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 Date05/31/2018
Device Model NumberCMRM6122
Device Catalogue NumberCMRM6122
Device Lot NumberR097456
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2018
Initial Report FDA Received Date06/07/2019
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
W1DR01 IPG, 5076-65 LEAD, 5076-58 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age50 YR
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