MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-25 for PILLCAM manufactured by Given Imaging, Inc..
[36722981]
Patient Sequence No: 1, Text Type: N, H10
[36722982]
The capsule was placed endoscopically and data recorder was attached. After capsule was removed from the patient and connected to the computer, there was no video recorded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5387506 |
| MDR Report Key | 5387506 |
| Date Received | 2016-01-25 |
| Date of Report | 2016-01-15 |
| Date of Event | 2015-10-21 |
| Report Date | 2015-12-29 |
| Date Reported to FDA | 2015-12-29 |
| Date Reported to Mfgr | 2015-12-29 |
| Date Added to Maude | 2016-01-25 |
| 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 |
| 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 | 2016-01-25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING, INC. |
| Manufacturer Address | 3950 SHACKLEFORD ROAD SUITE 500 DULUTH GA 30096 US 30096 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-25 |