MAUDE Adverse Event Report: FIXODENT DENTAL POWDER

Device Problem Insufficient Information (3190)

Patient Problems Nausea (1970); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Event Description

Lead taste in mouth.Lost all sense of taste.Since pulling rigident and polygrip off the shelves, have had to use fixodent powder.Have lost appetite because cannot taste food this powder has very strong taste and i actually feel nauseated.I feel that both rigident and polygrip were a much better product.It is a shame that no one is leaving us much choice in this matter.I read the warnings about fixodent powder and, and to be sure, it looks worse people out there that feel as discouraged as i do.Bottom line is that fixodent powder needs to be checked before it chokes someone.Thank you.

• Brand Name: FIXODENT DENTAL POWDER
• Type of Device: DENTAL POWDER
• MDR Report Key: 4466637
• MDR Text Key: 18891618
• Report Number: MW5040488
• Device Sequence Number: 1
• Product Code: KOO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 54