MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-06 for SMARTPILL GI MONITORING SYSTEM PH.P CAPSULE 50100100 manufactured by The Smartpill Corporation.
[2506472]
The subject had difficulties swallowing the capsule. Additional water and apple sauce were given, but the subject vomited the capsule. He agreed to make a second effort, but experienced discomfort again and a feeling that the capsule was lodged in his throat. He vomited a couple of times and was referred to the er for evaluation. An x-ray image showed the capsule in the gastro-esophageal junction. Since the conservative treatment of liquid and bread did not resolve the problem, a gi consolation was requested. The gastroenterologist ordered endoscopic removal due to the smartpill wedge in the lower esophageal sphincter, causing acute obstruction. The subject was transferred back to the unit in the evening, he was on a liquid diet yesterday and he will be on a puree diet for two more days.
Patient Sequence No: 1, Text Type: D, B5
[9562461]
Pt had last follow-up visit on (b)(6) 2011. At that time there was no permanent disability or impairment. No additional patient follow-up is planned or needed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320877-2011-00002 |
| MDR Report Key | 2380513 |
| Report Source | 05 |
| Date Received | 2011-09-06 |
| Date of Report | 2011-09-02 |
| Date of Event | 2011-08-05 |
| Date Mfgr Received | 2011-08-06 |
| Device Manufacturer Date | 2011-04-26 |
| Date Added to Maude | 2011-12-20 |
| 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 | MR RONALD BRANDT |
| Manufacturer Street | 847 MAIN ST. |
| Manufacturer City | BUFFALO NY 142031109 |
| Manufacturer Country | US |
| Manufacturer Postal | 142031109 |
| Manufacturer Phone | 7168820701 |
| Manufacturer G1 | THE SMARTPILL CORPORATION |
| Manufacturer Street | 847 MAIN ST. |
| Manufacturer City | BUFFALO NY 14203110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14203 1109 |
| Single Use | 3 |
| 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 | 2011-09-06 |
| Model Number | PH.P CAPSULE |
| Catalog Number | 50100100 |
| Lot Number | SPC1111601 |
| Device Expiration Date | 2012-01-15 |
| Operator | HEALTH PROFESSIONAL |
| 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 14203110 US 14203 1109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-06 |