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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROCTER & GAMBLE MANUFACTURING CO. CRESTWHTNGSYSSTRIPS+LIGHTWHITESTRIP3DWHITENOFLAVORSCENT WHITENING STRIPS

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PROCTER & GAMBLE MANUFACTURING CO. CRESTWHTNGSYSSTRIPS+LIGHTWHITESTRIP3DWHITENOFLAVORSCENT WHITENING STRIPS Back to Search Results
Lot Number NOT AVAILABLE
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Sensitivity of Teeth (2427); Tooth Fracture (2428)
Event Date 04/20/2018
Event Type  Injury  
Manufacturer Narrative

Product and lot number not provided by the reporter, therefore unable to proceed with product investigation at this time. There is not enough information to determine that there is not a causal link established between the alleged serious injury and crest whitestrip light use based on information that is known to procter & gamble, therefore we are reporting out of an abundance of caution.

 
Event Description

Small piece of front tooth chipped off (tooth fracture) teeth sensitive to heat and cold (sensitivity of teeth) cold air hurts teeth (toothache) case description: report source: spontaneous. A consumer of unspecified age and gender reported via e-mail on 21-apr-2018 that he/she used crest whitening systems strips + light whitestrip 3d white no flavor-scent beginning in (b)(6) 2018, and his/her teeth have since been sensitive to heat and cold, cold air hurts teeth when breathing with mouth open, and a small piece of a front tooth chipped off on (b)(6) 2018. The consumer reported the jagged edge of the tooth needed to be filed down. The case outcome was not recovered/ not resolved. Treatment details: unknown. Relevant history: none reported. Concomitant product(s): none reported. No further information was provided.

 
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Brand NameCRESTWHTNGSYSSTRIPS+LIGHTWHITESTRIP3DWHITENOFLAVORSCENT
Type of DeviceWHITENING STRIPS
Manufacturer (Section D)
PROCTER & GAMBLE MANUFACTURING CO.
6200 bryan park road
brown summit NC 27214
Manufacturer (Section G)
PROCTER & GAMBLE MANUFACTURING CO.
6200 bryan park road
brown summit NC 27214
Manufacturer Contact
regulatory oral care
8700 mason-montgomery rd
mason, OH 45040
MDR Report Key7530270
MDR Text Key108867391
Report Number1530449-2018-00002
Device Sequence Number1
Product Code MAU
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 04/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device LOT NumberNOT AVAILABLE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/21/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/21/2018 Patient Sequence Number: 1
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