FDA Adverse Event
Injury
Summary report: N
SPINBRUSH PROCLEAN SONIC TOOTHBRUSH
MDR report key: 2003755
·
Received February 24, 2011
Report
- Report Number
- 2280705-2011-00003
- Event Type
- Injury
- Date Received
- February 24, 2011
- Date of Event
- January 31, 2011
- Report Date
- February 11, 2011
- Manufacturer
- CHURCH & DWIGHT CO., INC.
- Product Code
- JEQ
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO FOR SECTION. THE BODY WAS MADE AT THE FOLLOWING LOCATION. CONTRACT MFR: HAYCO LTD, (B)(6). CONSUMER HAS NOT RETURNED PRODUCT TO DATE, THEREFORE, IT COULD NOT BE EVALUATED AND NO CONCLUSIONS COULD BE DRAWN.
Description of Event or Problem · 1
CONSUMER REPORTED THE HEAD CAME OFF WHEN HE WAS BRUSHING HIS TEETH. THE METAL PART JABBED INTO HIS CHEEK AND ALMOST WENT ALL THE WAY THROUGH. HE SOUGHT MEDICAL TREATMENT AND RECEIVED A TETANUS SHOT AND A Z-PACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINBRUSH PROCLEAN SONIC TOOTHBRUSH | TOOTHBRUSH, POWERED 872.6865 (JEQ) | JEQ | CHURCH & DWIGHT CO., INC. | 6687800162 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |