Brand Name | MEVION S250 |
Type of Device | MEVION S250 PROTON THERAPY SYSTEM |
Manufacturer (Section D) |
MEVION MEDICAL SYSTEMS, INC. |
300 foster street |
littleton MA 01460 |
|
Manufacturer (Section G) |
MEVION MEDICAL SYSTEMS, INC. |
300 foster street |
|
littleton MA 01460 |
|
Manufacturer Contact |
thomas
faris
|
300 foster street |
littleton, MA 01460
|
9785401500
|
|
MDR Report Key | 6249580 |
MDR Text Key | 64779264 |
Report Number | 3007087027-2017-00004 |
Device Sequence Number | 1 |
Product Code |
LHN
|
UDI-Device Identifier | 00864366000100 |
UDI-Public | (01)00864366000100(11)150526 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K120676 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
01/13/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | MEVION S250 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/05/2017 |
Initial Date FDA Received | 01/13/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/26/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|