FDA Adverse Event
Malfunction
Summary report: N
SPINBRUSH REPLACEMENT HEADS
MDR report key: 2852375
·
Received November 13, 2012
Report
- Report Number
- 2280705-2012-00147
- Event Type
- Malfunction
- Date Received
- November 13, 2012
- Report Date
- November 12, 2012
- Manufacturer
- CHURCH & DWIGHT CO., INC.
- Product Code
- JEQ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT USED WAS EITHER SPINBRUSH PRO WHITENING SOFT REPLACEMENT HEADS (B)(4), SPINBRUSH PRO WHITENING MEDIUM REPLACEMENT HEADS (B)(4), SPINBRUSH PROCLEAN SOFT REPLACEMENT HEADS (B)(4), OR SPINBRUSH PROCLEAN MEDIUM REPLACEMENT HEADS (B)(4). (B)(4).
Description of Event or Problem · 1
CONSUMER REPORTS TOOTHBRUSH HEAD BREAKAGE. THIS IS REPORTED AS A MALFUNCTION WITH THE POTENTIAL TO CAUSE SERIOUS INJURY. NO INJURY OCCURRED. THIS IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW TO IDENTIFY MALFUNCTIONS WITH THE POTENTIAL TO CAUSE SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINBRUSH REPLACEMENT HEADS | TOOTHBRUSH, POWERED SEC 872.6865 (JEQ) | JEQ | CHURCH & DWIGHT CO., INC. | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |