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U.S. Department of Health and Human Services

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

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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); Erythema (1840); Unspecified Infection (1930); Pain (1994)
Event Date 12/02/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that ten days post implant of an antibacterial absorbable envelope, the patient experienced pain at the implant site. The patient was brought in for assessment and it was found that the pocket was red and feverish with an opening at the incision and an infection was confirmed. Antibiotic treatment was administered and the antibacterial absorbable envelope remains in the patient. 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)
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 Key12977212
MDR Text Key282057664
Report Number2182208-2021-04861
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot NumberR149877
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/12/2021
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: 12/10/2021 Patient Sequence Number: 1
Treatment
ST. JUDE DEVICE, ST. JUDE LEAD
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