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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TENEX HEALTH, INC. TXB TISSUE REMOVAL SYSTEM - MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL
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TENEX HEALTH, INC. TXB TISSUE REMOVAL SYSTEM - MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Model Number 554-3003-001
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 12/31/2019
Type of Reportable Event Serious Injury
Event or Problem Description
A physician reported bleeding and an infection following a procedure with the tx system in a webinar presentation.The complication occurred around the operative site in the foot of the patient.There was also a report of recurrent calcification in the tendon above the heel six months after treatment.The procedure was performed by a different physician than the one who presented the webinar.
 
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Brand Name
TXB TISSUE REMOVAL SYSTEM - MICROTIP
Common Device Name
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
TENEX HEALTH, INC.
26902 vista terrace
lake forest CA 92630 8123
MDR Report Key10782043
Report Number1000135560-2020-00045
Device Sequence Number11722655
Product Code LFL
UDI-Device Identifier00857156006093
UDI-Public00857156006093
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K181367
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional,literatur
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number554-3003-001
Device Catalogue Number554-3003-001
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/12/2020
Initial Report FDA Received Date11/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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