MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-05 for X DR SERIES 1600 manufactured by Imaging Dynamics Company Ltd..
[3391602]
Imaging dynamics refusal to comply with a request for 21cfr instructions pursuant to 21cfr 1020. 30-g-h, 1020. 31, 1020. 32 and 820. 170.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029694 |
| MDR Report Key | 3052809 |
| Date Received | 2013-04-05 |
| Date of Report | 2013-04-05 |
| Date of Event | 2013-04-05 |
| Date Added to Maude | 2013-04-15 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | X DR SERIES 1600 |
| Generic Name | X DR SERIES 1600 |
| Product Code | JAD |
| Date Received | 2013-04-05 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMAGING DYNAMICS COMPANY LTD. |
| Manufacturer Address | 1157 - 40 AVENUE NE CALGARY T2E6M9 CA T2E 6M9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-05 |