PARABATH *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-29 for PARABATH * manufactured by Talcott Laboratories Inc..

Event Text Entries

[120605] Rptr rec'd second degree burns on their lt hand after using the device. Pt was hospitalized for 3 days, and healing took over 3-4 wks.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1014261
• MDR Report Key: 179569
• Date Received: 1998-07-29
• Date of Report: 1998-07-29
• Date of Event: 1998-05-11
• Date Added to Maude: 1998-07-31
• 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: PARABATH
• Generic Name: PARAFFIN BATH FOR PAIN, PERSONAL HYGIENE & HEALTH CARE APPLI
• Product Code: IMC
• Date Received: 1998-07-29
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 174606
• Manufacturer: TALCOTT LABORATORIES INC.
• Manufacturer Address: 301 E. BARR ST. MCDONALD PA 15057 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1998-07-29