Brand Name | ONCENTRA BRACHY |
Type of Device | SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED |
Manufacturer (Section D) |
NUCLETRON B.V. |
waardgelder 1 |
veenendaal 3905 TH |
NL 3905 TH |
|
Manufacturer (Section G) |
NUCLETRON B.V. |
waardgelder 1 |
|
veenendaal 3905 TH |
NL
3905 TH
|
|
Manufacturer Contact |
pms
|
cornerstone |
london road |
crawley, west sussex RH10 -9BL
|
UK
RH10 9BL
|
|
MDR Report Key | 12613703 |
MDR Text Key | 280932393 |
Report Number | 9611894-2021-00002 |
Device Sequence Number | 1 |
Product Code |
JAQ
|
UDI-Device Identifier | 08717213052314 |
UDI-Public | 08717213052314 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K132816 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/04/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/12/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 170003-28 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/13/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|