MAUDE Adverse Event Report: THE PROCTER & GAMBLE COMPANY ARC WHITENING SYSTEMS STRIPS + LIGHT WHITESTRIP 3D WHITE NO FLAVOR-SCENT * COUNT; ERASER, DENTAL STAIN

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Event Description

Teeth cracking, chipping [tooth fracture].Hurt - teeth [toothache].A spontaneous report was received via an internet rating/review site on cracking from a consumer, unknown age and gender, stating that he/she used arc whitening systems strips + light whitestrip cracking while no flavor-scent 8 count box and it hurt so bad, he/she took a break from it and tried it again, and now his/her teeth are cracking and chipping.The consumer reported that he/she called the dentist to get the teeth checked out.The case outcome was not recovered/not resolved.Cracking on dechallenge-yes.Recur on rechallenge-yes.Taken previously- unknown/tolerated - unknown.Treatment details: unknown.Relevant history: none reported, concomitant product(s): none reported.No further information was provided.

• Type of Device: ERASER, DENTAL STAIN
• Manufacturer (Section D): THE PROCTER & GAMBLE COMPANY; 8700 mason-montgomery road; mason business ctr; mason OH 45040 9462
• MDR Report Key: 11131651
• MDR Text Key: 225778942
• Report Number: MW5098712
• Device Sequence Number: 1
• Product Code: MAU
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other