MAUDE Adverse Event Report: TOWER LABORATORIES, LTD. TOPCARE DOUBLE ACTION DENTURE CLEANSER ; EFFERVESCENT DENTURE CLNR

Lot Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 10/22/2015

Event Type  Other  

Event Description

Consumer reported having used the topcare double action denture cleanser and has developed blisters on the inside of his mouth which as a result is very painful.

• Brand Name: TOPCARE DOUBLE ACTION DENTURE CLEANSER
• Type of Device: EFFERVESCENT DENTURE CLNR
• Manufacturer (Section D): TOWER LABORATORIES, LTD.; centerbrook CT
• Manufacturer Contact: 8 industrial park rd.; p.o. box 306; centerbrook, CT 06409 ; 8607674881
• MDR Report Key: 5200560
• MDR Text Key: 30506854
• Report Number: 1219540-2015-00005
• 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: company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/28/2015

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 10/29/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR