MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-09 for PILLCAM FGS-0400 manufactured by Given Imaging Ltd., Yoqneam.
[182525417]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182525418]
According to the reporter, the patient noticed a gap on the capsule when it was excreted. The gap was between the dome and the capsule body. They will check whether the parts of the capsule remained in the body. An extended hospitalization was necessary. The patient had more diarrhea and would need a stoma. They will decide on an operation and they would like to know if the adverse event was associated with the capsule.
Patient Sequence No: 1, Text Type: D, B5
[189070533]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[189070534]
According to the reporter, after excreting the capsule the patient noticed a gap between the dome and the capsule body. Hospitalization was necessary. The patient had diarrhea and needed a stoma. The patient's pre-procedure diagnosis was positive hemoccult (blood in the stool) and the patient had no known diarrhea before the capsule procedure. After the prolonged diarrhea, the patient was sent to a second hospital where his situation impaired. The patient was then transferred to a third hospital and was sent to intensive care unit. The patient had cdi (c. Difficile infection). The capsule images were carefully reviewed and the medical advisor stated that it did not appear that there was a relationship between the suspected gap and the patient's condition. The reporting physician also clarified there was no relationship between the capsule endoscopy and the patient's subsequent infectious disease and death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2020-00111 |
| MDR Report Key | 9805018 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2020-03-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-09 |
| Model Number | FGS-0400 |
| Catalog Number | FGS-0400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-09 |