ELECTROSURGICAL COAGULATION FOR AESTHETIC TC3000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-22 for ELECTROSURGICAL COAGULATION FOR AESTHETIC TC3000 manufactured by F Care Systems Usa Llc.

Event Text Entries

[22194856] We have experienced both burning and bleeding when using this device on the face. When using this device on a client around her nose, the probe end began to spark and then actually burned the client's skin. I immediately discontinued the service, but the device was smoking and gave off an electrical smell. I unplugged the device and called the manufacturer. He took the device back, "made an adjustment" and sent it back to us. Additionally, the device causes bleeding on the skin. No where in the manual is it indicated that this is supposed to happen. The procedure is not invasive, we apply pressure with the probe significant enough to close down the superficial vessels in the skin, but the probe is not sharp and does not penetrate the skin. In the manufacturer's consent; coumadin, aspirin or other blood thinners are listed as a contraindication, so we do not perform this on them, but bleeding occurs in most eligible clients during care. We had a demonstration with a similar device, not a tc3000, but a more advanced device by the same inventor, and were told by the representative that bleeding is not supposed to occur. To confirm that is was not technique, we used our device on the company representative, and he bled. Bleeding interferes with the treatment, as success depends on a completely dry field. It is also a universal precaution. Tc3000 device to treat spider veins. This device is fda approved under the 510k number k083352.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5033035
MDR Report Key3486378
Date Received2013-11-22
Date of Report2013-06-26
Date of Event2012-05-01
Date Added to Maude2013-11-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameELECTROSURGICAL COAGULATION FOR AESTHETIC
Generic NameELECTROSURGICAL COAGULATION FOR AESTHETIC
Product CodeONQ
Date Received2013-11-22
Model NumberTC3000
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerF CARE SYSTEMS USA LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2013-11-22

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