MAUDE Adverse Event Report: TOWER LABORATORIES LTD. EXACT ANTIBACTERIAL DENTURE CLEANSER OVERNIGHT; OVERNIGHT DENTURE CLEANSER TABLETS

Lot Number 6215065

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

Patient Problem Death (1802)

Event Date 11/15/2016

Event Type  Death  

Event Description

Patient had dementia.Reporter (patient's daughter) explained she witnessed him, at some point, chew a denture cleanser tablet to clean his teeth.She is not sure how often or how long he was using the product that way.She told him not to chew the product.At a later date, the patient died from corrosion in his upper gi tract where he had internal bleeding.The daughter believes this condition was caused by his consumption of the denture cleanser tablets.

• Brand Name: EXACT ANTIBACTERIAL DENTURE CLEANSER OVERNIGHT
• Type of Device: OVERNIGHT DENTURE CLEANSER TABLETS
• Manufacturer (Section D): TOWER LABORATORIES LTD.; 8 industrial park road; centerbrook CT 06409
• Manufacturer Contact: crystal fisher ; 8 industrial park road; centerbrook, CT 06409 ; 8607672127
• MDR Report Key: 6910532
• MDR Text Key: 88013272
• Report Number: 3005596071-2017-00001
• 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: distributor
• Type of Report: Initial
• Report Date: 05/30/2017

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: 08/08/2019
• Device Lot Number: 6215065
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death