MAUDE Adverse Event Report: TOWER LABORATORIES, LTD. EQUATE ANTIBACTERIAL DENTURE CLEANSER; EFFERVESCENT DENTURE CLNR

Device Problem Insufficient Information (3190)

Patient Problems Nausea (1970); No Code Available (3191)

Event Date 02/26/2014

Event Type  Other  

Event Description

Consumer reported having used the equate antibacterial denture cleanser for approximately 2 months to clean his dentures.He has been feeling nausea and states he has a metallic taste in his mouth.

• Brand Name: EQUATE ANTIBACTERIAL DENTURE CLEANSER
• Type of Device: EFFERVESCENT DENTURE CLNR
• Manufacturer (Section D): TOWER LABORATORIES, LTD.; centerbrook CT
• Manufacturer Contact: 8 industrial park rd.; po box 306; centerbrook, CT 06409 ; 8607674881
• MDR Report Key: 3767738
• MDR Text Key: 4362122
• Report Number: 1219540-2014-00002
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2014
• Initial Date FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR