MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for CRESTWHTNGSYSSTRIPS+LIGHTWHITESTRIP3DWHITENOFLAVORSCENT manufactured by Procter & Gamble Manufacturing Co..
[108867391]
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.
Patient Sequence No: 1, Text Type: N, H10
[108867392]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2018-00002 |
| MDR Report Key | 7530270 |
| Date Received | 2018-05-21 |
| Date of Report | 2018-04-21 |
| Date of Event | 2018-04-20 |
| Date Mfgr Received | 2017-04-21 |
| Date Added to Maude | 2018-05-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. REGULATORY ORAL CARE |
| Manufacturer Street | 8700 MASON-MONTGOMERY RD |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer G1 | PROCTER & GAMBLE MANUFACTURING CO. |
| Manufacturer Street | 6200 BRYAN PARK ROAD |
| Manufacturer City | BROWN SUMMIT NC 27214 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27214 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRESTWHTNGSYSSTRIPS+LIGHTWHITESTRIP3DWHITENOFLAVORSCENT |
| Generic Name | WHITENING STRIPS |
| Product Code | MAU |
| Date Received | 2018-05-21 |
| Lot Number | NOT AVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE MANUFACTURING CO. |
| Manufacturer Address | 6200 BRYAN PARK ROAD BROWN SUMMIT NC 27214 US 27214 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-21 |