Brand Name | EXTERNAL BEAM RADIATION |
Type of Device | SYSTEM RADIATION THERAPY, CHARGED - PARTICLE, MEDICAL |
MDR Report Key | 8692851 |
MDR Text Key | 147993105 |
Report Number | MW5087308 |
Device Sequence Number | 1 |
Product Code |
LHN
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
PATIENT
|
Type of Report
| Initial |
Report Date |
06/07/2019 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 06/11/2019 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
NO INFORMATION
|
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
No Answer Provided
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Was Device Evaluated By Manufacturer? |
|
Is The Device Single Use? |
|
Is this a Reprocessed and Reused Single-Use Device? |
|
Type of Device Usage |
|
Patient TREATMENT DATA |
Date Received: 06/11/2019 Patient Sequence Number: 1 |
|
|