FDA Adverse Event
Injury
Summary report: N
REACH ACCESS DAILY FLOSSER
MDR report key: 1040265
·
Received May 8, 2008
Report
- Report Number
- 8041101-2008-00007
- Event Type
- Injury
- Date Received
- May 8, 2008
- Report Date
- May 8, 2008
- Manufacturer
- JOHNSON & JOHNSON HEALTHCARE PRODUCTS
- Product Code
- JES
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AFTER FLOSSING UPPER TEETH, WHILE TRYING TO REMOVE THE FLOSS FROM BETWEEN TEETH, FLOSSER CAME DOWN, HIT BOTTOM MOLAR HARD, RESULTING IN CRACKED TOOTH. SAW DENTIST. POTENTIALLY COULD RESULT IN ROOT CANAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REACH ACCESS DAILY FLOSSER | DENTAL FLOSS | JES | JOHNSON & JOHNSON HEALTHCARE PRODUCTS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |