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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TENEX HEALTH, INC. TENEX HEALTH TX SYSTEM - WITH TXB MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL
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TENEX HEALTH, INC. TENEX HEALTH TX SYSTEM - WITH TXB MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Model Number 554-3003-001
Device Problem Use of Device Problem (1670)
Patient Problem Burn, Thermal (2530)
Event Date 11/14/2019
Event Type  Injury  
Manufacturer Narrative
It appears that the user used a smaller than specified bag of saline for irrigation, and a shorter than specified off-time for the duty cycle of use.These could have contributed to extra heat generation by the microtip.
 
Event Description
Following a procedure with the tenex system, blisters and skin burns were observed near the needle incision point.The patient was treated with antibiotics and healed normally.
 
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Brand Name
TENEX HEALTH TX SYSTEM - WITH TXB MICROTIP
Type of Device
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
TENEX HEALTH, INC.
26902 vista terrace
lake forest CA 92630 8123
Manufacturer (Section G)
TENEX HEALTH, INC.
26902 vista terrace
lake forest CA 92630
Manufacturer Contact
david vancelette
26902 vista terrace
lake forest, CA 92630
9492388220
MDR Report Key9577850
MDR Text Key174579536
Report Number1000135560-2020-00002
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number554-3003-001
Device Catalogue Number554-3003-001
Was Device Available for Evaluation? No
Date Manufacturer Received12/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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