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U.S. Department of Health and Human Services

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

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THE PROCTER & GAMBLE COMPANY ARC WHITENING SYSTEMS STRIPS + LIGHT WHITESTRIP 3D WHITE NO FLAVOR-SCENT * COUNT ERASER, DENTAL STAIN Back to Search Results
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.

 
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Type of DeviceERASER, DENTAL STAIN
Manufacturer (Section D)
THE PROCTER & GAMBLE COMPANY
8700 mason-montgomery road
mason business ctr
mason OH 45040 9462
MDR Report Key11131651
MDR Text Key225778942
Report NumberMW5098712
Device Sequence Number1
Product Code MAU
Combination Product (Y/N)Y
Number of Events Reported1
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 Received01/06/2021
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 the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/06/2021 Patient Sequence Number: 1
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