FDA Adverse Event
Other
Summary report: N
SONICARE DIAMOND CLEAN BRUSH HEAD
MDR report key: 6266342
·
Received January 18, 2017
Report
- Report Number
- MW5067334
- Event Type
- Other
- Date Received
- January 18, 2017
- Date of Event
- December 15, 2016
- Manufacturer
- PHILIPS ORAL HEALTHCARE INC.
- Product Code
- JEQ
- Report Source
- Voluntary report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE SONICARE DIAMOND CLEAN BRUSH HEAD HAD A SMALL PLASTIC PIECE THAT WAS PROTRUDING FROM THE BRUSH HEAD. I USED THE HEAD AND IT SCRATCHED THE INSIDE OF MY MOUTH. I CONTACTED PHILIPS AND THEY NEEDED PROOF OF PURCHASE PLUS MULTIPLE DETAILS (PHOTOS), ETC WHICH SEEMED EXCESSIVE FOR A DEFECTIVE PRODUCT. ALSO, THEY NEED 2-3 DAYS TO REVIEW MY PROOF OF PURCHASE BEFORE THEY WILL RESPOND. INJURY, NO FIRST AID OR MEDICAL ATTENTION RECEIVED. PRODUCT TYPE: GROOMING. RETAILER: (B)(4). RETAILER STATED: (B)(4). PURCHASE DATE: (B)(6) 2016. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. DOCUMENT NUMBER: (B)(4), REPORT NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 44403 | SONICARE DIAMOND CLEAN BRUSH HEAD | SONICARE DIAMOND CLEAN BRUSH HEAD | JEQ | PHILIPS ORAL HEALTHCARE INC. | HX6950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |