• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, 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
 

MEDTRONIC, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number CMRM6133
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Bruise/Contusion (1754); Hematoma (1884); Unspecified Infection (1930); Pain (1994)
Event Date 04/02/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: 5076-52 lead, implant date (b)(6) 2020; w1dr01 ipg, implant date (b)(6) 2020; pb1018 transcatheter valve. Implant date (b)(6) 2019. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the patient experienced pocket infection, pocket hematoma, open incision, bruising and pain approximately five weeks after a revision procedure involving the implant of an absorbable envelope. The implantable pulse generator (ipg) system was explanted and replaced. No further patient complications have been reported as a result of this event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10009237
MDR Text Key189609684
Report Number2182208-2020-00830
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130943
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2020
Device MODEL NumberCMRM6133
Device Catalogue NumberCMRM6133
Device LOT NumberR123607
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/03/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/29/2020 Patient Sequence Number: 1
-
-