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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROCTER & GAMBLE CO. GLEEM WHITENING SYSTEMS STRIPS + (CONTINUED) ERASER, DENTAL STAIN

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PROCTER & GAMBLE CO. GLEEM WHITENING SYSTEMS STRIPS + (CONTINUED) ERASER, DENTAL STAIN Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Sensitivity of Teeth (2427); Tooth Fracture (2428)
Event Type  Injury  
Event Description

Chips of teeth coming out [tooth fracture]. Teeth sensitive [hyperaesthesia teeth] (continued). Teeth painfully [toothache]. A consumer of case description: a consumer of unspecified age and gender reported spontaneously via e-mail on (b)(6) 2020 that he/she used gleem whitening systems strips + light whllestrip 3d white beginning on an unspecified dale. The consumer explained that after using the product, his/her teeth had become very painfully sensitive and chips of his/her teeth were coming out. The case outcome was unknown. Treatment details; unknown. Relevant history: none reported. Concomitant product(s); none.

 
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Brand NameGLEEM WHITENING SYSTEMS STRIPS + (CONTINUED)
Type of DeviceERASER, DENTAL STAIN
Manufacturer (Section D)
PROCTER & GAMBLE CO.
MDR Report Key10599223
MDR Text Key209153892
Report NumberMW5096910
Device Sequence Number1
Product Code MAU
Combination Product (Y/N)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 05/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2020
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: 09/28/2020 Patient Sequence Number: 1
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