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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 Problems Syncope (1610); Dyspnea (1816); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Swelling (2091); Blurred Vision (2137); Dizziness (2194)
Event Date 06/16/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 2088tc lead, implanted: (b)(6) 1999 ; product id: 1388tc lead, implanted: (b)(6) 1999. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported by the patient that they experienced swelling and shortness of breath post implant procedure. It was also reported that the patient experienced dizziness, fatigue, lack of appetite, blurred vision. It was suspected that this was an allergy to the implantable pulse generator (ipg) or the antibacterial absorbable envelope implanted with ipg. The implantable pulse generator (ipg) and absorable envelope 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 jct,nj MN 08852
Manufacturer (Section G)
TYRX, INC.
1 deer park dr.
suites g, e
monmouth jct,nj MN 08852
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10377727
MDR Text Key202021189
Report Number6000030-2020-00184
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130943
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 08/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTYRX-AAE
Device Catalogue NumberTYRX-AAE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2020
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: 08/07/2020 Patient Sequence Number: 1
Treatment
W3DR01 IPG
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