MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-25 for PILLCAM FGS-0501 manufactured by Given Imaging Ltd., Yoqneam.
[185481369]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185481370]
According to the reporter, they had a patient in which the capsule was retained for over 7 months. Patency capsule was performed prior to the procedure. The patient reported vomiting, discomfort, and losing weight but it was unclear whether or not this has been continuous and for how long this has been going on. The capsule retention was verified initially through abdominal x-ray and it showed that it had not reached the cecum. This was also confirmed with a subsequent ct scan. The patient went through several serial abdominal x-rays to assess passage. Once it was apparent that the capsule had not passed after several weeks, it was recommended to have the patient start corticosteroids for active inflammation secondary to crohn's disease in which the patient refused. They suspected that the capsule was stuck proximal to an inflammatory stricture and treatment of this may aid in capsule passage. It was also recommended that the patient start biologic therapy which the patient also refused. The patient was referred to an institution that could perform double balloon enteroscopy but was not able to be seen there. The patient underwent retrograde single balloon enteroscopy which failed in reaching the capsule. The patient was last seen on (b)(6) 2020 in which they had the failed single balloon enteroscopy, since then, the patient missed office follow up. There was no user harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2020-00147 |
| MDR Report Key | 9881010 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-08-15 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2018-12-25 |
| Date Added to Maude | 2020-03-25 |
| 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 Country | IL |
| 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 | 2020-03-25 |
| Model Number | FGS-0501 |
| Catalog Number | FGS-0501 |
| Lot Number | 43953S |
| 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 IL 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |