MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-02 for PILLCAM FGS-0391 manufactured by Given Imaging Ltd., Yoqneam.
[177235256]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177235257]
According to the reporter, the capsule was retained. There was no reported patient outcome.
Patient Sequence No: 1, Text Type: D, B5
[182654331]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182654332]
According to the reporter, the capsule was retained. They checked the capsule location with an abdominal x-ray which showed the capsule was still retained in the small bowel and the capsule has not been removed surgically. The patient reported that they can feel the capsule in the lower abdominal umbilical area. The patient had a stricture and they need to ensure that the patient had a patency capsule first.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2020-00005 |
| MDR Report Key | 9540358 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-01-02 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-01-02 |
| 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, GASTROINTESTINAL, WIRELESS, CAPSULE |
| Product Code | NEZ |
| Date Received | 2020-01-02 |
| Model Number | FGS-0391 |
| Catalog Number | FGS-0391 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-02 |