BIOTRON *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-07-02 for BIOTRON * manufactured by Biotron.

Event Text Entries

[277681] Event date approximation of date pt began seeing a nurse using galvanic skin response measurement device mfg by biotron. She claimed to be able to detect both the presence and absence of cancer cells in various organs and the lymphatic system with this machine. Pt was diagnosed with melanoma. They declined "traditional" treatment with hosp and was monitored and treated by nurse with previously mentioned device. When this nurse first saw pt, she told pt they were cancer-free. She indicated to rptr that she had detected cancer cells several times during the 2-year period of visits, however, she "got rid of them". Saw her approx 9 hrs prior to their death. She stated then that she could not detect the presence of cancer cells in pt's body, only arsenic.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1025561
MDR Report Key	404756
Date Received	2002-07-03
Date of Report	2002-07-02
Date of Event	2000-08-01
Date Added to Maude	2002-07-16
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	PATIENT FAMILY MEMBER OR FRIEND
Health Professional	3
Initial Report to FDA	0
Report to FDA	0
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	BIOTRON
Generic Name	GALVANIC SKIN RESPONSE MEASUREMENT DEVICE
Product Code	GZO
Date Received	2002-07-02
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	393753
Manufacturer	BIOTRON
Manufacturer Address	UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2002-07-03