MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-21 for INTELEPACS (INTELEVIEWER) INTELEVIEWER 4-17-1 AND UP manufactured by Intelerad Medical Systems.
| Report Number | 9615916-2020-00001 |
| MDR Report Key | 9611265 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-20 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2018-10-12 |
| Date Added to Maude | 2020-01-21 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. LAUREN BOCQUET |
| Manufacturer Street | 800, BOUL. DE MAISONNEUVE E. 12TH FLOOR |
| Manufacturer City | MONTREAL, QUEBEC H2L 4L8 |
| Manufacturer Country | CA |
| Manufacturer Postal | H2L 4L8 |
| Manufacturer G1 | INTELERAD MEDICAL SYSTEMS |
| Manufacturer Street | 800, BOUL. DE MAISONNEUVE E. 12TH FLOOR |
| Manufacturer City | MONTREAL, QUEBEC H2L 4L8 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | H2L 4L8 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELEPACS (INTELEVIEWER) |
| Generic Name | PICTURE ARCHIVING AND COMMUNICATION SYSTEM |
| Product Code | LLZ |
| Date Received | 2020-01-21 |
| Model Number | INTELEVIEWER 4-17-1 AND UP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTELERAD MEDICAL SYSTEMS |
| Manufacturer Address | 800, BOUL. DE MAISONNEUVE E. 12TH FLOOR MONTREAL, QUEBEC H2L 4L8 CA H2L 4L8 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-21 |