* UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-14 for * UNK manufactured by *.

Event Text Entries

[355218] Pt had been asthmatic for over 20 years. Pt was treated for asthma in 2002 following a pneumonia. Pt was put on prednisone and levaquin. Pt lost weight and energy and had to stop the steroid. They took solace in chiropractice where the device was used on them and they were told they scored low with regards to their heart, pituitary, thyroid, nervous system and were given a combination of medications including acidophil, lympao-liquirophic, hypo-gest, daily complete; trace minerals, cataplex acp pneumo carotene, lympho-liquitrophic, hypo-gest, daily complete, trace minerals, cataplex acp, pneumo-carotene. The pt did not feel better. Instead, their ankle, calves and feet became swollen and they became extremely weak. Pt had been reluctant to go back to the doctor for fear of being put on steroids and at the same time is scared of visiting the chiropractice office because the last time they visited the doctor they had vials of "stem cells" in their refrigerator which he wanted to test on pt but they refused.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1032081
• MDR Report Key: 527630
• Date Received: 2004-05-14
• Date of Report: 2004-05-14
• Date of Event: 2002-07-26
• Date Added to Maude: 2004-06-03
• 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
• 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: COMPUTER DIAGNOSTIC SCREENING
• Product Code: HCC
• Date Received: 2004-05-14
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: OTHER
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 516800
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2004-05-14