MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-09-27 for PILLCAM FGS-0109 manufactured by Given Imaging Ltd., Yoqneam.
[122102101]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[122102102]
According to the reporter, there was an undissolved patency capsule found in the patient? S feces with blood from a relatively small bowel stenosis. The capsule only dissolved a little at both ends, which should have been dissolved after 36 hours. The patient had ileus symptoms, which led to hospitalization and then the patient did not have later complications after the hospitalization. There was no reported patient outcome.
Patient Sequence No: 1, Text Type: D, B5
[135535404]
Correction:if information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[135535425]
According to the reporter, there was an undissolved patency capsule found in the patient? S feces with blood from a relative small bowel stenosis. The capsule only dissolved a little in both ends, which should have been dissolved after 36 hours. The capsule was used in accordance with the instructions for use and subsequently medical intervention was necessary, resulting in hospitalization of the patient after passing of the capsule. The patient had ileus symptoms which led to hospitalization and then the patient did not have later complications after the hospitalization. There was no reported patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2018-00962 |
| MDR Report Key | 7916680 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-27 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-05-07 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2017-08-13 |
| Date Added to Maude | 2018-09-27 |
| 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 | 2018-09-27 |
| Model Number | FGS-0109 |
| Catalog Number | FGS-0109 |
| Lot Number | 36752 |
| Device Expiration Date | 2018-08-13 |
| 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. Hospitalization | 2018-09-27 |