FDA Adverse Event
Injury
Summary report: N
WATER PIK
MDR report key: 61927
·
Received January 8, 1997
Report
- Report Number
- 1712259-1997-00001
- Event Type
- Injury
- Date Received
- January 8, 1997
- Date of Event
- December 11, 1996
- Manufacturer
- TELEDYNE WATER PIK
- Product Code
- JEQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THREE BRUSHES WERE RETURNED WITH THE UNIT. NONE OF THEM HAD ANY BROKEN PIECES. THE RETENTION FEATURE ON ONE BRUSH WAS BENT AND WOULD NOT HOLD THE BRUSH ON THE POWER HANDLE. ALL 3 BRUSHES SHOWED EVIDENCE OF BITE MARKS. THE POWER HANDLE SHOWED SOME EVIDENCE OF WEAR ON THE FLAT SURFACE ABOVE THE DETENT WHEN VIEWED UNDER AN OPTICAL COMPARATOR.
Description of Event or Problem · 1
CUSTOMER WAS CONTACTED TO CLARIFY THIS REPORT. MOTHER STATED THAT AS SHE WAS BRUSHING HER SONS TEETH, THE BRUSH CAME OFF. THE NEXT DAY HER HUSBAND WAS SUPERVISING THEIR SON; THE FATHER STEPPED OUT OF THE ROOM AND UPON HIS RETURN THEIR SON WAS CHOKING ON THE BRUSH. SHE SAID THAT THE BRUSH DID NOT BREAK, BUT THAT IT WOULD NOT STAY ON THE HANDLE. THE UNIT HAD BEEN USED FOR 5 YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WATER PIK | AUTOMATIC TOOTHBRUSH | JEQ | TELEDYNE WATER PIK | AT10W | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Life Threatening |