MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-01-09 for UNK-SMARTPILL UNKNOWN SMARTPILL manufactured by Given Imaging Ltd., Yoqneam.
[132567204]
Title: role of wireless motility capsule in the assessment and management of gastrointestinal dysmotility in patients with diabetes mellitus. Source: (b)(6), department of gastroenterology and hepatology. Date: oct 2016. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[132567225]
According to the reporter, the patient had a capsule retained in the stomach, who was later found to have a gastric outlet obstruction during endoscopy for capsule retrieval and was eventually diagnosed with metastatic cancer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2019-00017 |
| MDR Report Key | 8232189 |
| Report Source | LITERATURE |
| Date Received | 2019-01-09 |
| Date of Report | 2019-01-09 |
| Date of Event | 2017-03-13 |
| Date Mfgr Received | 2018-12-12 |
| Date Added to Maude | 2019-01-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Street | YETSIRA 13 STREET |
| Manufacturer City | YOQNEAM 20692 |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK-SMARTPILL |
| Generic Name | GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE |
| Product Code | NYV |
| Date Received | 2019-01-09 |
| Model Number | UNKNOWN SMARTPILL |
| Catalog Number | UNKNOWN SMARTPILL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Address | YETSIRA 13 STREET YOQNEAM 20692 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-09 |