FIXODENT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-22 for FIXODENT * manufactured by Procter And Gamble Co..

Event Text Entries

[17255031] Heart began to race, dizziness, disorientation, fainting, nausea and was "totally incapacitated" like being on acid. This began within 1 hour of consumption. The consumer noted tape on the cardboard container flap, the tube appeared to have been squeezed at the bottom. The consumer did not seek medical attention. The consumer contacted the retailer who contacted the mfr. The health dept has the sample.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003815
• MDR Report Key: 562459
• Date Received: 2004-09-22
• Date of Report: 2004-08-30
• Date of Event: 2004-08-26
• Date Added to Maude: 2005-01-03
• 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: 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: FIXODENT
• Generic Name: FIXODENT ADHESIVE CREAM
• Product Code: KOP
• Date Received: 2004-09-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 552177
• Manufacturer: PROCTER AND GAMBLE CO.
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-09-22