COLGATE PLATINUM OVERNIGHT PROFESSIONAL WHITENING SYSTEM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-09-19 for COLGATE PLATINUM OVERNIGHT PROFESSIONAL WHITENING SYSTEM * manufactured by Colgate.

Event Text Entries

[209594] Bleached teeth for two nights and teeth hurt really bad. Called dentist and was informed to wait two nights and bleach again. Then bleached again 6 days after initial event. Next day went to see dentist. Showed dentist blisters on inside of lip. Informed to skip 2 to 3 nights and bleach again. Waited 6 days and it caused teeth to hurt badly again. Did not bleach anymore. Couldn't stand the pain anymore. For about 1 month continued to go to dentist once/twice weekly. Dentist put gel and sealant on teeth with extreme pain. Dentist saw tiny fractures on these teeth. Consumer used over-the-counter (advil, ultram) meds, but finally dentist prescribed prevident 5000. Later the same year their physician sent pt to endodontist for pain. Root canal was performed. Ended up having 2 more root canals and surgery on 1st root canal and tooth next to it. Then had a tooth extraction on tooth that had first root canal. Took about 11 months for pain to improve, but still bothers pt some. Pt states had pain, suffering and expense. When pt discovered 1-800-consumer number in 1/01, they informed consumer that product shouldn't have been used on sensitive teeth or teeth with hairline fractures, but states this was not on the box label.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1022868
• MDR Report Key: 352060
• Date Received: 2001-09-19
• Date of Report: 2001-09-19
• Date of Event: 2000-09-18
• Date Added to Maude: 2001-09-20
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COLGATE PLATINUM OVERNIGHT PROFESSIONAL WHITENING SYSTEM
• Generic Name: PROFESSIONAL WHITENING SYSTEM
• Product Code: JER
• Date Received: 2001-09-19
• Model Number: *
• Catalog Number: *
• Lot Number: 911001C
• ID Number: *
• Device Expiration Date: 2001-05-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 341346
• Manufacturer: COLGATE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-09-19