BEST PRO 1 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-09 for BEST PRO 1 * manufactured by Avazzia.

Event Text Entries

[540815] Pt is seeking treatment for breast cancer at clinic and she was concerned about testimonials on website misrepresenting devices (best pro 1 and tennant biomodulator by avazzia) as treatment for cancer. Apparently devices work by sending electronic waves into the skin and activating the nerves to cause healing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4004086
• MDR Report Key: 758567
• Date Received: 2005-11-09
• Date of Report: 2005-07-28
• Date Added to Maude: 2006-09-12
• 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: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: BEST PRO 1
• Generic Name: *
• Product Code: HCC
• Date Received: 2005-11-09
• Model Number: *
• Catalog Number: *
• Lot Number: NA
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 746488
• Manufacturer: AVAZZIA
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: TENNANT BIOMODULATOR
• Generic Name: *
• Product Code: HCC
• Date Received: 2005-11-09
• Model Number: *
• Catalog Number: *
• Lot Number: NA
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 746491
• Manufacturer: AVAZZIA
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-11-09