HAUSMAN PARABATH *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-28 for HAUSMAN PARABATH * manufactured by Hausman Industries, Inc.

Event Text Entries

[18156400] One of the heating elements overheated causing the surface to get too hot.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 318027
• MDR Report Key: 318027
• Date Received: 2001-02-28
• Date of Report: 2001-02-28
• Date of Event: 2001-02-16
• Date Facility Aware: 2001-02-19
• Report Date: 2001-02-28
• Date Reported to FDA: 2001-02-28
• Date Reported to Mfgr: 2001-02-28
• Date Added to Maude: 2001-03-02
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HAUSMAN PARABATH
• Generic Name: PARAFFIN BATH
• Product Code: IMC
• Date Received: 2001-02-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: MFR DATE 1988
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 13 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 307544
• Manufacturer: HAUSMAN INDUSTRIES, INC
• Manufacturer Address: 130 UNION STREET NORTHBALE NJ 07647 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-02-28