MAUDE Adverse Event Report: RICE CREEK MFG TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE; MESH, SURGICAL, POLYMERIC

Model Number	CMRM6133
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling (2091)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5076-52 lead, implanted: (b)(6) 2012-12; 6947-65 lead, implanted: (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient had an implantable cardioverter defibrillator (icd) change in which a large absorbable antibacterial envelope was used.The patient developed swelling over the icd pocket soon after the device change.The icd system was removed due to an infection.The patient was administered with antibiotics immediately at first signs of infection and after device system removal.The icd system was not replaced.No further patient complications have been reported as a result of this event.

• 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 Key: 9860579
• Report Number: 6000030-2020-00147
• Device Sequence Number: 2611616
• Product Code: FTL
• UDI-Device Identifier: 00763000101619
• UDI-Public: 00763000101619
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2020

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 Date: 12/31/2019
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: R121014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DDMB1D1 ICD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR