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 2020-01-22 for PILLCAM FGS-0347 manufactured by Given Imaging Ltd., Yoqneam.
[176069893]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176069934]
According to the reporter, the recorder prompted an error 62 message which meant that the sd card contributed to the failure of the data retrieval. The patient had to extend hospitalization for another day because of the repeat procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2020-00035 |
| MDR Report Key | 9618617 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-22 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2019-12-30 |
| Date Added to Maude | 2020-01-22 |
| 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 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 | 2020-01-22 |
| Model Number | FGS-0347 |
| Catalog Number | FGS-0347 |
| 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. Hospitalization | 2020-01-22 |