MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-10-19 for SMARTPILL GI MONITORING SYSTEM PH.P CAPSULE 50100100 manufactured by The Smartpill Corporation.
[2464322]
The pt ingested the smartpill capsule on wednesday morning ((b)(6) 2011). She had no difficulty swallowing the smartpill. On saturday evening ((b)(6) 2011) she vomited the capsule up and chocked on it. She had to do the heimlich on herself and actually pulled the capsule from her throat. She reported to the doctor that she is doing okay, except her throat is a little sore from the capsule coming up.
Patient Sequence No: 1, Text Type: D, B5
[9562935]
Obstruction. Device lodged because of pt physiology.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320877-2011-00001 |
| MDR Report Key | 2380821 |
| Report Source | 05 |
| Date Received | 2011-10-19 |
| Date of Report | 2011-08-05 |
| Date of Event | 2011-07-27 |
| Date Mfgr Received | 2011-08-02 |
| Device Manufacturer Date | 2011-04-21 |
| 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 | 7168820201 |
| 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 | 2011-10-19 |
| Model Number | PH.P CAPSULE |
| Catalog Number | 50100100 |
| Lot Number | SPC1111101 |
| Device Expiration Date | 2012-01-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 14203110 US 14203 1109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-19 |