UNK NI NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-12-10 for UNK NI NA manufactured by Unk.

Event Text Entries

[20891939] Pt received a "treatment" at the spa for the advertised purpose of detoxification, anti-aging, addiction recovery, and immune system stimulation. Pt said that this treatment was provided in a steam cabinet. Pt sat inside the cabinet unclothed except for a towel which provided protection against the sides of the cabinet that were very hot. A towel was placed around pt's neck and the door of the cabinet was closed leaving only pt's head outside of the cabinet. Pt said that oxygen was pumped into cabinet by an oxygen generating machine and that an ionizing machine pumped negative ions into the steam cabinet. Pt noticed a malodorous smell of body odor on entering the steam cabinet and noted that there was no cleansing of the cabinet after the previous customer. Pt reports feeling sick with flu-like symptoms for a couple of days after the treatment. Specifically pt says they were nauseated, vomited, and had diarrhea for two days. Pt denies any skin irritation, and did not seek medical care.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003184
• MDR Report Key: 375703
• Date Received: 2001-12-10
• Date of Report: 2001-12-10
• Date of Event: 2001-11-13
• Date Added to Maude: 2002-02-11
• 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
• 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: UNK
• Generic Name: STEAM CABINET WITH OXYGEN
• Product Code: IMB
• Date Received: 2001-12-10
• Model Number: NI
• Catalog Number: NA
• Lot Number: NA
• ID Number: NI
• Operator: LAY USER/PATIENT
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 364791
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-12-10