FDA Adverse Event
Other
Summary report: N
SONICARE FLEXCARE
MDR report key: 1032498
·
Received April 21, 2008
Report
- Report Number
- 3026630-2008-00002
- Event Type
- Other
- Date Received
- April 21, 2008
- Date of Event
- March 4, 2008
- Report Date
- March 5, 2008
- Manufacturer
- PHILIPS ORAL HEALTHCARE
- Product Code
- JEQ
- PMA / PMN Number
- K040416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION OF THE DEVICE AND THE EVENT OCCURRENCE ARE UNDERWAY.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT HE PLUGGED THE SONICARE FLEXCARE POWERED TOOTHBRUSH IN AT HOME ON (B) (6) 2008 TO CHARGE IT. HE USED IT ONLY ONE TIME ON (B) (6) 2008 FOR 2 MINUTES. INCIDENT OCCURRED AFTER STEPPING IN THE SHOWER AFTER BRUSHING FOR 2 MINUTES. CUSTOMER CLAIMS FLEXCARE CAUSED HIS PACEMAKER TO PULSE ABNORMALLY FOR 3 TO 4 MINUTES AT HIGH MODE. CUSTOMER ALSO REPORTED THAT HE DID NOT READ THE DPU (DIRECTIONS FOR USE) PRIOR TO USE, WHICH STATES ON PAGE 5, "MEDICAL WARNINGS": ADDRESS QUESTIONS CONCERNING USAGE WITH A PACEMAKER OR OTHER IMPLANTED DEVICE TO YOUR PHYSICIAN OR THE IMPLANTED DEVICE MFR. CONSULT YOUR PHYSICIAN PRIOR TO USE THE SONICARE IF YOU HAVE MEDICAL CONCERNS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SONICARE FLEXCARE | TOOTHBRUSH, POWERED | JEQ | PHILIPS ORAL HEALTHCARE | 4235 010 06061 | 071101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | ST JUDE PACEMAER, MODEL #5386, (B) (4) |