MAUDE Adverse Event Report: TOWER LABORATORIES LTD EQUAT EFFERVESCENT DENTURE CLEANSER TABLETS

Lot Number 40820-6

Device Problem Reaction (1514)

Patient Problem Blister(s) (1743)

Event Date 01/21/2015

Event Type  No Answer Provided  

Event Description

Consumer alleges the equate double action effervescent denture cleanser caused red blisters / blotches in the roof of his mouth.

• Brand Name: EQUAT EFFERVESCENT DENTURE CLEANSER TABLETS
• Type of Device: EFFERVESCENT DENTURE CLEANSER TABLET
• Manufacturer (Section D): TOWER LABORATORIES LTD; centerbrook CT
• Manufacturer Contact: 8 industrial park rd.; centerbrook, CT 06409 ; 8607674881
• MDR Report Key: 4540572
• MDR Text Key: 5513788
• Report Number: 1219540-2015-00001
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/09/2015

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: 08/30/2017
• Device Lot Number: 40820-6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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 Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 61