MAUDE Adverse Event Report: TOWER LABORATORIES, LTD. EQUATE ANTIBACTERIAL DENTURE CLEANSER; EFFERVESCENT ANTIBACTERIAL DENTURE C

Lot Number 50902-8

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

Patient Problem Swelling (2091)

Event Date 11/16/2015

Event Type  No Answer Provided  

Event Description

Consumer experienced swelling of her face after using the equate antibacterial denture cleanser.This was her first time using this product.Medical attention was not sought.

• Brand Name: EQUATE ANTIBACTERIAL DENTURE CLEANSER
• Type of Device: EFFERVESCENT ANTIBACTERIAL DENTURE C
• Manufacturer (Section D): TOWER LABORATORIES, LTD.; centerbrook CT
• Manufacturer Contact: robert stone ; 8 industrial park rd.; centerbrook, CT 06409 ; 8607674881
• MDR Report Key: 5301874
• MDR Text Key: 33718951
• Report Number: 1219540-2015-00006
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 12/04/2015

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 Expiration Date: 09/01/2015
• Device Lot Number: 50902-8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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: 67 YR
• Patient Weight: 84