FDA Adverse Event
Other
Summary report: N
SIMPLISSE
MDR report key: 2900269
·
Received December 28, 2012
Report
- Report Number
- 3008138005-2012-00005
- Event Type
- Other
- Date Received
- December 28, 2012
- Date of Event
- December 17, 2012
- Report Date
- December 27, 2012
- 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) 2012, (B)(6) REPORTED THAT SHE HAD BEEN DIAGNOSED BY PHYSICIAN WITH MASTITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLISSE | DOUBLE ELECTRIC BREAST PUMP | HGY | HANDI-CRAFT COMPANY | S1005 | SP010131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Other |