FDA Adverse Event
Malfunction
Summary report: N
REACH JOHNSON & JOHNSON FLOSS FLOURIDE MINT WAXED
MDR report key: 2250569
·
Received September 16, 2011
Report
- Report Number
- 8041101-2011-00003
- Event Type
- Malfunction
- Date Received
- September 16, 2011
- Report Date
- September 16, 2011
- Manufacturer
- JOHNSON & JOHNSON CONSUMER PRODUCTS
- Product Code
- JES
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
Description of Event or Problem · 1
THIS SPONTANEOUS REPORT WAS RECEIVED ON 23-AUG-2011 CONCERNING A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER NOTICED THAT DISPENSER OF REACH JOHNSON & JOHNSON FLOSS FLUORIDE MINT WAXED (LOT NUMBER: 3480D AND EXPIRATION DATE: UNSPECIFIED) POPPED OFF AND THE PART THAT HAD CUTTER CAME OFF. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS NOT APPLICABLE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REACH JOHNSON & JOHNSON FLOSS FLOURIDE MINT WAXED | DENTAL FLOSS | JES | JOHNSON & JOHNSON CONSUMER PRODUCTS | REFFMWUS | 3480D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |