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

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.

• Brand Name: CRESTWHTNGSYSSTRIPS+LIGHTWHITESTRIP3DWHITENOFLAVORSCENT
• Type of Device: WHITENING 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 Key: 7530270
• MDR Text Key: 108867391
• Report Number: 1530449-2018-00002
• Device Sequence Number: 1
• Product Code: MAU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• 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 Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other