D
Patient 1
A FEMALE BROKE OUT IN MOUTH AREA AFTER USING PRODUCT. SYMPTOMS DID NOT ABATE AFTER SHE DISCONTINUED USING THE PRODUCT. SHE SAW A DOCTOR, HAD SURGERY. SYMPTOM SUGGEST HYPERSENSITIVITY REACTION.
MAUDE MDR 1004062
- MDR report key
- 1004062
- Report number
- 2648730-2008-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2006-07-04
- Date received
- 2008-02-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Address
- 199 GRANDVIEW RD SKILLMAN NJ 08558 US
- Phone
- 908-908-9088
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STIMUDENT PLAQUE REMOVER | INTERDENTAL PLAQUE REMOVER PICKS | JOHNSON & JOHNSON HEALTHCARE PRODUCTS | JET | NA | NA | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-02-27 | 0 | 1. R |