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

Lot Number 40535-2

Device Problem Insufficient Information (3190)

Patient Problem Burning Sensation (2146)

Event Date 07/31/2014

Event Type  No Answer Provided  

Event Description

Consumer purchased equate antibacterial denture cleanser to clean his dentures.Every time he used the product, it causes him a burning sensation in his mouth.

• Brand Name: EQUATEEFFERVESCENT ANTIBACTERIAL DENTURE CLEANSER TABLETS
• Type of Device: EFFERVESCENT DENTURE CLEANSER
• 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: 4081267
• MDR Text Key: 4826205
• Report Number: 1219540-2014-00006
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

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: 05/31/2017
• Device Lot Number: 40535-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: 85 YR
• Patient Weight: 88