MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-30 for PILLCAM RECORDER DR2 manufactured by Given Imagining.
[5302037]
Indicator lights on pillcam recorder were not on. Recorder returned by patient to endo dept. And data recorder was off-reason unknown. Recorder restarted without difficulty. Manufacturer - given imaging states user issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039946 |
| MDR Report Key | 4387134 |
| Date Received | 2014-12-30 |
| Date of Report | 2014-12-29 |
| Date of Event | 2014-01-29 |
| Date Added to Maude | 2015-01-07 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLCAM RECORDER |
| Generic Name | RECORDER-PILLCAM |
| Product Code | NSI |
| Date Received | 2014-12-30 |
| Model Number | DR2 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGINING |
| Manufacturer Address | OAKVILLE, ONTARO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-30 |