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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 CMRM6133
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 03/01/2021
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: 429888 lead implanted: (b)(6) 2014; dtma1qq 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 presented for a routine wound check post generator replacement and a hematoma was noted. The patient had taken anticoagulation medication even though was instructed not to. A pressure dressing was applied and the patient was re-evaluated 2 days later. Due to the hematoma not resolving the patient was admitted for 2 days for observation and to ensure the anticoagulation medication was not being taken. After discharge the patient was seen for continued observation and rebandaging. Due to oozing from the lateral edge of the incision the patient was taken to the lab to drain the hematoma. The hematoma was drained, extensive clot and remnants of the antibacterial absorbable envelope were removed, and the pocket was reclosed. The device remains in use. The patient is a participant in a clinical study. 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 Key11602582
MDR Text Key243361305
Report Number3005619263-2021-00014
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 HEALTH PROFESSIONAL,STUDY
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/08/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberCMRM6133
Device Catalogue NumberCMRM6133
Device LOT NumberR138705
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 Received04/06/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/27/2020
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: 04/01/2021 Patient Sequence Number: 1
Treatment
5076-45 LEAD, 6947M55 LEAD
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