Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TYRX, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE; MESH, SURGICAL, POLYMERIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 12/12/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 694965 lead, implanted: (b)(6) 2004, 5076-52 lead, implanted: (b)(6) 2004.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 three weeks after implant of the implantable cardioverter defibrillator (icd) with an antibacterial absorbable envelope.The icd system will be explanted.No further patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9572385
Report Number3005619263-2020-00001
Device Sequence Number10872174
Product Code FTL
UDI-Device Identifier00763000101619
UDI-Public00763000101619
Combination Product (Y/N)N
Initial Reporter StateGA
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) 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 NumberR119514
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/12/2019
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
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age74 YR
Patient Weight86
-
-