MAUDE Adverse Event Report: TOWER LABORATORIES LTD. UP & UP ANTIBACTERIAL DENTURE CLEANSER; DENTURE CLEANSER TABLETS

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Several attempts have been made to contact patient via phone to get additional information pertinent to the specific lot of product she used.Since our attempts have been unsuccessful, we have sent out a letter to the address provided in hopes we will obtain samples of product along with the information that could help us conduct a more detailed investigation.

Event Description

Patient claims after using the up & up antibacterial denture cleanser to clean her dentures, she developed an infection which spread to her eye requiring surgical intervention.The patient believes the denture cleanser product is the root cause for the infection.

• Brand Name: UP & UP ANTIBACTERIAL DENTURE CLEANSER
• Type of Device: 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: 6955651
• MDR Text Key: 89523687
• Report Number: 0001219540-2017-00002
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/25/2017

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other