MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-20 for SMARTPILL GI MONITORING SYSTEM, PHP CAPSULE manufactured by The Smartpill Corporation.
[1078896]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320877-2009-00001 |
| MDR Report Key | 1353986 |
| Report Source | 05 |
| Date Received | 2009-03-20 |
| Date of Report | 2009-03-17 |
| Date of Event | 2009-02-25 |
| Date Mfgr Received | 2009-02-27 |
| Date Added to Maude | 2010-08-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHLEEN SELOVER |
| Manufacturer Street | 847 MAIN ST. |
| Manufacturer City | BUFFALO NY 14203 |
| Manufacturer Country | US |
| Manufacturer Postal | 14203 |
| Manufacturer Phone | 7168820701 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTPILL GI MONITORING SYSTEM, PHP CAPSULE |
| Product Code | NYV |
| Date Received | 2009-03-20 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE SMARTPILL CORPORATION |
| Manufacturer Address | 847 MAIN ST. BUFFALO NY 14203 US 14203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-03-20 |