KY WARMING ULTRA GEL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-07-27 for KY WARMING ULTRA GEL * manufactured by *.

Event Text Entries

[507192] A severe case of contact dermatitis after using ky warming ultra gel. Was attended to by her husband, dr.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003980
• MDR Report Key: 757610
• Date Received: 2005-07-27
• Date of Report: 2005-04-18
• Date of Event: 2005-03-25
• Date Added to Maude: 2006-09-07
• 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: 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: KY WARMING ULTRA GEL
• Generic Name: *
• Product Code: MMS
• Date Received: 2005-07-27
• Model Number: *
• Catalog Number: *
• Lot Number: 0184C
• ID Number: *
• Device Expiration Date: 2006-05-01
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 745507
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-07-27