MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for PHANTOMMSK HIP /PHANTOM MSK manufactured by Orthogrid Systems, Inc..
[180632251]
System failure. Test did not happen. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093112 |
| MDR Report Key | 9733315 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-15 |
| Date Added to Maude | 2020-02-20 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHANTOMMSK HIP |
| Generic Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Product Code | LLZ |
| Date Received | 2020-02-19 |
| Model Number | /PHANTOM MSK |
| Lot Number | 2.4.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOGRID SYSTEMS, INC. |
| Product Code | --- |
| Date Received | 2020-02-19 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-19 |