MAUDE Adverse Event Report: TOWER LABORATORIES LTD EQUATE EFFERVESCENT DOUBLE ACTION DENTURE CLEANSER TABLETS; EFFERVESCENT DENTURE CLEANSER TABLETS

Lot Number 31257-5

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 05/25/2014

Event Type  No Answer Provided  

Event Description

Reporter/patient ms.(b)(6) alleges that she has been using the equate denture cleanser from (b)(6) 2014 and the product has caused her mouth to become really sore.She had to go to the doctors because she did not know why she could not eat.

• Brand Name: EQUATE EFFERVESCENT DOUBLE ACTION DENTURE CLEANSER TABLETS
• Type of Device: EFFERVESCENT DENTURE CLEANSER TABLETS
• Manufacturer (Section D): TOWER LABORATORIES LTD; 8 industrial park road; centerbrook CT 06409
• Manufacturer (Section G): TOWER LABORATORIES LTD; 8 industrial park road; centerbrook CT 06409
• Manufacturer Contact: robert stone ; 8 industrial park road; centerbrook, CT 06409 ; 8607672127
• MDR Report Key: 3876017
• MDR Text Key: 21494700
• Report Number: 1219540-2014-00003
• 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: User Facility,Company Representative,Distributor
• Type of Report: Initial
• Report Date: 06/16/2014

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: 12/31/2016
• Device Lot Number: 31257-5
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2013
• 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: 70 YR
• Patient Weight: 48