STERM INHALER 11 SI NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1999-02-08 for STERM INHALER 11 SI NA manufactured by Kaz, Inc..

Event Text Entries

[21606362] Consumer reported spilling hot water from unit while carrying it. Hot water burned right hand.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1314800-1998-00026
• MDR Report Key: 209252
• Report Source: 04
• Date Received: 1999-02-08
• Date of Report: 1999-02-05
• Date of Event: 1998-12-15
• Date Mfgr Received: 1999-02-05
• Date Added to Maude: 1999-02-11
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STERM INHALER
• Generic Name: STEAM INHALER
• Product Code: KFC
• Date Received: 1999-02-08
• Model Number: 11 SI
• Catalog Number: NA
• Lot Number: NA
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 203075
• Manufacturer: KAZ, INC.
• Manufacturer Address: ONE VAPOR TRAIL HUDSON NY 12534 US
• Baseline Brand Name: STERM INHALER
• Baseline Generic Name: STEAM INHALER
• Baseline Model No: 11 SI
• Baseline Catalog No: NA
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-02-08