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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TYRX, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC

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TYRX, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TYRX-AAE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 03/11/2021
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the patient developed a pocket infection approximately five weeks post the implantation of an implantable pulse generator (ipg) system with a antibacterial absorbable envelope. The ipg system was removed. Cultures were taken and medication was administered. As the patient was dependent an external temporary pacing device was used. Six days later a leadless pacemaker was implanted. No further patient complications have been reported as a result of this event.

 
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Brand NameTYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TYRX, INC.
1 deer park dr.
suites g, e
monmouth jct NJ 08852
Manufacturer (Section G)
TYRX, INC.
1 deer park dr.
suites g, e
monmouth jct NJ 08852
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11619367
MDR Text Key243943783
Report Number3005619263-2021-00015
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
Report Date 04/06/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberTYRX-AAE
Device Catalogue NumberTYRX-AAE
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 Received03/11/2021
Was Device Evaluated By Manufacturer? No Answer Provided
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: 04/06/2021 Patient Sequence Number: 1
Treatment
W1DR01 IPG, 5076-52 LEAD, 5076-45 LEAD
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