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 2020-01-28 for PILLCAM FGS-0109 manufactured by Given Imaging Ltd., Yoqneam.
[178204867]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178204868]
According to the reporter, the patency capsule was retained for over 72 hours. There was no patient and user harm.
Patient Sequence No: 1, Text Type: D, B5
[182654849]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182654850]
According to the reporter, the patency capsule was retained for over 72 hours. The customer confirmed that the capsule was retained at the ileo-ileal anastomosis by performing a plain abdominal x-ray. 1 week later a follow up x ray was performed, and it did not show the radio frequency id tag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2020-00040 |
| MDR Report Key | 9640140 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-28 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-10-28 |
| Date Added to Maude | 2020-01-28 |
| 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 | 2020-01-28 |
| Model Number | FGS-0109 |
| Catalog Number | FGS-0109 |
| Lot Number | 48180 |
| 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 | 2020-01-28 |