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

Lot Number 50331-4

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem Itching Sensation (1943)

Event Date 04/15/2015

Event Type  Other  

Event Description

Pt stated she is allergic to yellow dye and the yellow dye from the equate double action denture cleanser caused her to itch.

• Brand Name: EQUATE 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: 4843840
• MDR Text Key: 16560518
• Report Number: 1219540-2015-00003
• 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: Company Representative
• Type of Report: Initial
• Report Date: 06/08/2015

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: 03/30/2018
• Device Lot Number: 50331-4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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: 66 YR
• Patient Weight: 77