FDA Adverse Event
Malfunction
Summary report: N
CHILDRENS SPARKLE TOOTHBRUSH - IMPRINT (144 CT), PS - ALG
MDR report key: 6152457
·
Received December 7, 2016
Report
- Report Number
- 2024980-2016-00008
- Event Type
- Malfunction
- Date Received
- December 7, 2016
- Date of Event
- November 9, 2016
- Report Date
- November 29, 2016
- Manufacturer
- YOUNG INNOVATIONS LLC DBA PLAK SMACKER
- Product Code
- EFW
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS DISCARDED BY THE END USER, UNABLE TO FOLLOW UP.
Description of Event or Problem · 1
PLAK SMACKER RECEIVED A COMPLAINT SAYING THAT A TOOTHBRUSH DISINTEGRATED IN A (B)(6) YEAR OLD GIRL'S MOUTH AND SHE MIGHT HAVE SWALLOWED SOME BRISTLES. THERE WAS NOT ANY TREATMENT AFTER THIS HAPPENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 803353 | CHILDRENS SPARKLE TOOTHBRUSH - IMPRINT (144 CT), PS - ALG | CHILDRENS SPARKLE TOOTHBRUSH - IMPRINT (144 CT), PS - ALG | EFW | YOUNG INNOVATIONS LLC DBA PLAK SMACKER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 YR | Other |