MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-11-02 for PILLCAM FGS-0109 manufactured by Given Imaging Ltd., Yoqneam.
[126061524]
Title detection of small bowel mucosal healing and deep remission in patients with known small bowel crohn? S disease using biomarkers, capsule endoscopy, and imaging source the american journal of gastroenterology, volume 110, 2015(1316-1323) date of publication: 28 july 2015. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[126061525]
According to literature source of study performed, one patient had a symptomatic patency capsule retention manifesting with abdominal pain and vomiting. The patient was treated with corticosteroids with subsequent resolution of the symptoms within 2 days. Article: detection of small bowel mucosal healing and deep remission in patients with known small bowel crohn? S disease using biomarkers, capsule endoscopy, and imaging author: uri kopylov , md, year: 2015 september volume110.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2018-01022 |
| MDR Report Key | 8035216 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-11-02 |
| Date of Report | 2018-11-02 |
| Date Mfgr Received | 2018-10-08 |
| Date Added to Maude | 2018-11-02 |
| 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 | PILLCAM |
| Generic Name | SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE |
| Product Code | NSI |
| Date Received | 2018-11-02 |
| Model Number | FGS-0109 |
| Catalog Number | FGS-0109 |
| Operator | HEALTH PROFESSIONAL |
| 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. Required No Informationntervention | 2018-11-02 |