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

Lot Number 40992-2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 11/01/2014

Event Type  No Answer Provided  

Event Description

Patient / consumer stated the equate antibacterial denture cleanser caused her mouth to burn and hurt.This was the consumers first time using this product.Medical attention was not sought.

• Brand Name: EQUATE EFFERVESCENT ANTIBACTERIAL DENTURE CLEANSER
• Type of Device: EFFERVESCENT DENTURE CLEANSER
• Manufacturer (Section D): TOWER LABORATORIES LTD; 8 industrial park road; po box 306; centerbrook CT 06409
• Manufacturer Contact: robert stone ; 8 industrial park road; po box 306; centerbrook, CT 06409 ; 8607672127
• MDR Report Key: 4239843
• MDR Text Key: 4990546
• Report Number: 1219540-2014-00009
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2014

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: 09/30/2017
• Device Lot Number: 40992-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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 Age: 92 YR