MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-29 for PILLCAM FGS-0155 manufactured by Given Imaging, Inc..
[118543201]
Patient was scheduled for an m2a study but we were unable to capture data/read study. Patient will need to repeat study at different time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7826086 |
| MDR Report Key | 7826086 |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-06 |
| Date of Event | 2018-07-31 |
| Report Date | 2018-08-06 |
| Date Reported to FDA | 2018-08-06 |
| Date Reported to Mfgr | 2018-08-29 |
| Date Added to Maude | 2018-08-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 2018-08-29 |
| Model Number | FGS-0155 |
| Catalog Number | FGS-0155 |
| Lot Number | 40041S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING, INC. |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |