FDA Adverse Event
Injury
Summary report: N
SMARTPILL GI MONITORING SYSTEM
MDR report key: 2380821
·
Received October 19, 2011
Report
- Report Number
- 1320877-2011-00001
- Event Type
- Injury
- Date Received
- October 19, 2011
- Date of Event
- July 27, 2011
- Report Date
- August 5, 2011
- Manufacturer
- THE SMARTPILL CORPORATION
- Product Code
- NYV
- PMA / PMN Number
- K092342
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
OBSTRUCTION. DEVICE LODGED BECAUSE OF PT PHYSIOLOGY.
Description of Event or Problem · 1
THE PT INGESTED THE SMARTPILL CAPSULE ON WEDNESDAY MORNING ((B)(6) 2011). SHE HAD NO DIFFICULTY SWALLOWING THE SMARTPILL. ON SATURDAY EVENING ((B)(6) 2011) SHE VOMITED THE CAPSULE UP AND CHOCKED ON IT. SHE HAD TO DO THE HEIMLICH ON HERSELF AND ACTUALLY PULLED THE CAPSULE FROM HER THROAT. SHE REPORTED TO THE DOCTOR THAT SHE IS DOING OKAY, EXCEPT HER THROAT IS A LITTLE SORE FROM THE CAPSULE COMING UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTPILL GI MONITORING SYSTEM | GASTROINTESTINAL MOTILITY CAPSULE | NYV | THE SMARTPILL CORPORATION | PH.P CAPSULE | SPC1111101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |