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

Lot Number 50120-6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); No Code Available (3191)

Event Date 07/28/2015

Event Type  Other  

Event Description

Consumer reported having used the equate antibacterial denture cleanser and afterwards left a bad taste in her mouth and her tongue became red.She did not seek medical attention.

• 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 road ; po box 306; centerbrook, CT 06409 ; 8607674881
• MDR Report Key: 5022529
• MDR Text Key: 24584631
• Report Number: 1219540-2015-00004
• 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
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2018
• Device Lot Number: 50120-6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 62