MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-01-26 for SMARTPILL GI MONITORING SYSTEM PH.P CAPSULE 50100500 manufactured by The Smartpill Corporation.
[19206346]
Pt underwent capsule motility procedure and ingested smartpill capsule. 24 to 30 hours after ingestion pt went to emergency room complaining, he had something caught in his throat. X-ray showed foreign body, identified by radiologist as "a light bulb-like object" in the lower esophagus above the les. Egd performed and foreign body removed. Pt discharged. Pt's private physician identified object as smartpill capsule. Pt seen by his physician - no further issues due to egd, retained foreign object, or object removal.
Patient Sequence No: 1, Text Type: D, B5
[19426334]
(b) (4) - device lodged because of pt physiology.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320877-2010-00001 |
| MDR Report Key | 1590928 |
| Report Source | 05 |
| Date Received | 2010-01-26 |
| Date of Report | 2010-01-26 |
| Date of Event | 2009-12-10 |
| Date Mfgr Received | 2009-12-10 |
| Date Added to Maude | 2010-02-03 |
| 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 | 0 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTPILL GI MONITORING SYSTEM |
| Generic Name | GASTROINTESTINAL MOTILITY CAPSULE |
| Product Code | NYV |
| Date Received | 2010-01-26 |
| Model Number | PH.P CAPSULE |
| Catalog Number | 50100500 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2010-01-26 |