MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-06-24 for SMARTPILL GI MONITORING SYSTEM, PHP CAPSULE manufactured by The Smartpill Corporation.
[864672]
Gastric emptying evaluation ordered as patient has multiple gi disorders and is candidate for gastric neurostimator. Ingested capsule in '08 and subsequently reported worsening nausea and vomiting. Ct of abdomen showed capsule in the pyloric region. About 4 days later, endoscopy performed and confirmed that the capsule was lodged in the pylorus. Capsule successfully retrieved. Patient discharged in the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320877-2008-00001 |
| MDR Report Key | 1065327 |
| Report Source | 05 |
| Date Received | 2008-06-24 |
| Date of Report | 2008-06-23 |
| Date of Event | 2008-03-26 |
| Date Mfgr Received | 2008-06-09 |
| Date Added to Maude | 2008-07-01 |
| 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 STREET |
| 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 | 2008-06-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1033834 |
| Manufacturer | THE SMARTPILL CORPORATION |
| Manufacturer Address | 847 MAIN STREET BUFFALO NY 14055 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-06-24 |