MAUDE Adverse Event Report: TOWER LABORATORIES LTD EQUATE EFFERVESCENT DOUBLE ACTION DENTURE CLEANSER TABLETS; EFFERVESCENT DENTURE CLEANSER TABLETS

Device Problem Insufficient Information (3190)

Patient Problems Neurological Deficit/Dysfunction (1982); Burning Sensation (2146)

Event Date 10/21/2014

Event Type  No Answer Provided  

Event Description

Patient/consumer claims that after leaving his dentures over night in the equate double action denture cleanser solution, he felt a burning sensation in his mouth and a strong metallic taste.

Manufacturer Narrative

Lot number unknown.

• Brand Name: EQUATE EFFERVESCENT DOUBLE ACTION DENTURE CLEANSER TABLETS
• Type of Device: EFFERVESCENT DENTURE CLEANSER TABLETS
• Manufacturer (Section D): TOWER LABORATORIES LTD; 8 industrial park road; po box 306; centerbrook CT 06409
• Manufacturer (Section G): TOWER LABORATORIES LTD; 8 industrial park road; po box 306; centerbrook CT 06409
• MDR Report Key: 4239766
• MDR Text Key: 5060165
• Report Number: 1219540-2014-00008
• 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: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2014

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 Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 106