FDA Adverse Event
Injury
Summary report: N
TELEDYNE WATER PIK
MDR report key: 105314
·
Received July 11, 1997
Report
- Report Number
- 1712259-1997-00003
- Event Type
- Injury
- Date Received
- July 11, 1997
- Date of Event
- May 4, 1997
- Report Date
- July 11, 1997
- Manufacturer
- TELEDYNE WATER PIK
- Product Code
- JEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
THE MOTHER CONTACTED THE CO ON 16 JUNE 97 TO REPORT THAT MEDICAL INTERVENTION WAS NECESSARY TO MONITOR AND HELP PASS A TOOTHBRUSH HEAD FROM HER SON'S COLON. THE 10 YR OLD BOY SWALLOWED THE TOOTHBRUSH HEAD ON 4 MAY 97. THE PROGRESS OF THE TOOTHBRUSH WAS MONITORED WITH THE AID OF DIAGNOSTIC X-RAY. THE LAST REPORT CONCLUDES THAT THE TOOTHBRUSH HAS PASSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELEDYNE WATER PIK | AUTOMATIC TOOTHBRUSH | JEQ | TELEDYNE WATER PIK | PC 3000W | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |