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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 Hematoma (1884)
Event Date 03/03/2021
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: ddmc3d1 icd, implanted: (b)(6) 2021. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the patient developed a hematoma following a device implant with an antibacterial absorbable envelope. The hematoma was evacuated and the implantable cardioverter defibrillator (icd) remains in use. 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 junction NJ 08852
Manufacturer (Section G)
TYRX, INC
1 deer park dr
suites g, e
monmouth junction NJ 08852
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11473675
MDR Text Key239428171
Report Number3005619263-2021-00008
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 03/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2021
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 Received03/03/2021
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: 03/12/2021 Patient Sequence Number: 1
Treatment
5076-52 LEAD
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