MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-09-18 for PILLCAM FGS-0109 manufactured by Given Imaging Ltd., Yoqneam.
[120691256]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[120691257]
According to the reporter, the patency capsule was still in the ascending colon of the patient as confirmed by the computed tomography and three x-ray's. The patient was then admitted for gastrointestinal bleeding and has a history of colon cancer. The medical advisor explained to the customer that the patency capsule will dissolve and will be expulsed naturally, and that it will be defined as a retained capsule after fifteen days. The patient had a history of prior gastrointestinal bleeding, melena, and colon cancer. The patient is still hospitalized, additional diagnosis pneumonitis and will continue to be monitored and the physician will decide the best action. The x-ray showed some colonic diverticular present and the capsule was seen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2018-00951 |
| MDR Report Key | 7887381 |
| Report Source | USER FACILITY |
| Date Received | 2018-09-18 |
| Date of Report | 2018-09-18 |
| Date of Event | 2018-08-24 |
| Date Mfgr Received | 2018-08-28 |
| Date Added to Maude | 2018-09-18 |
| 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 | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| 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 | 2018-09-18 |
| Model Number | FGS-0109 |
| Catalog Number | FGS-0109 |
| Lot Number | 39952 |
| Device Expiration Date | 2019-03-12 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-09-18 |