FDA Adverse Event
Other
Summary report: N
SIMPLISSE BY DR. BROWN
MDR report key: 3409247
·
Received October 3, 2013
Report
- Report Number
- 3008138005-2013-00006
- Event Type
- Other
- Date Received
- October 3, 2013
- Date of Event
- September 3, 2013
- Report Date
- October 3, 2013
- Manufacturer
- HANDI-CRAFT COMPANY
- Product Code
- HGY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON (B)(6) 2013 CASE (B)(4) REPORTED THAT SHE HAD BEEN DIAGNOSED BY A PHYSICIAN WITH MASTITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 499631 | SIMPLISSE BY DR. BROWN | NONE | HGY | HANDI-CRAFT COMPANY | S1006 | SPO 10207 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |