Brand Name | SONOPLEX |
Type of Device | PERIPHERAL NERVE BLOCK NEEDLE |
Manufacturer (Section D) |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
karl-hall-str. 1 |
geisingen, baden-wuerttemberg 78187 |
GM 78187 |
|
Manufacturer (Section G) |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
karl-hall-str. 1 |
|
geisingen, baden-wuerttemberg 78187 |
GM
78187
|
|
Manufacturer Contact |
christian
quass
|
karl-hall-str. 1 |
regulatory & safety affairs |
geisingen, baden-wuerttemberg 78187
|
GM
78187
|
7704929158
|
|
MDR Report Key | 6197503 |
MDR Text Key | 63486838 |
Report Number | 9611612-2016-00158 |
Device Sequence Number | 1 |
Product Code |
BSP
|
UDI-Device Identifier | 04048223018965 |
UDI-Public | 04048223018965 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K111374 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/14/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 06/01/2021 |
Device Model Number | 001185-31G |
Device Catalogue Number | 001185-31G |
Device Lot Number | 1166 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/07/2016
|
Initial Date FDA Received | 12/22/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/14/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/01/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|