*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-06 for * manufactured by Unk.

Event Text Entries

[20426117] Family member sent a letter describing how they feel the pt is being taken in by the referenced health clinic, and that they are using an acupuncture type diagnostic device telling the pt of numerous conditions they are suffering from. Family member also states that the pt's regular md does not feel the pt has those conditions.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003498
• MDR Report Key: 458119
• Date Received: 2003-03-06
• Date of Report: 2003-03-06
• Date Added to Maude: 2003-05-08
• 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: *
• Generic Name: VOLL MACHINE
• Product Code: BWJ
• Date Received: 2003-03-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 447100
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2003-03-06