FDA Adverse Event
Other
Summary report: N
SMARTPILL GI MONITORING SYSTEM, PHP CAPSULE
MDR report key: 1353986
·
Received March 20, 2009
Report
- Report Number
- 1320877-2009-00001
- Event Type
- Other
- Date Received
- March 20, 2009
- Date of Event
- February 25, 2009
- Report Date
- March 17, 2009
- Manufacturer
- THE SMARTPILL CORPORATION
- Product Code
- NYV
- PMA / PMN Number
- K053547
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CAPSULE MOTILITY PROCEDURE ORDERED FOR PT BECAUSE OF PRESENTING SYMPTOMS OF GASTROPARESIS - EARLY SATIETY, BLOATING, BELCHING. CAPSULE INGESTED ON (B)(6)2009. ON (B)(6)2009, PT COMPLAINED OF ABDOMINAL PAIN AND CRAMPING. PHYSICIAN DETERMINED CAPSULE BECAME LODGED IN THE SMALL INTESTINE "LEVEL WITH THE ILLEUM." PT HOSPITALIZED AND GIVEN IV FLUIDS, NG TUBE, BED REST. OBSTRUCTION RESOLVED WITHIN 48 HRS. PT DISCHARGED, DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTPILL GI MONITORING SYSTEM, PHP CAPSULE | NYV | THE SMARTPILL CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization |