Brand Name | SPROTTE 2.G |
Type of Device | SPINAL ANAESTHESIA/ LUMBAR PUNCTURE 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 |
geisingen, baden-wuerttemberg 78187
|
GM
78187
|
|
MDR Report Key | 7005453 |
MDR Text Key | 92488995 |
Report Number | 9611612-2017-00012 |
Device Sequence Number | 1 |
Product Code |
BSP
|
UDI-Device Identifier | 14048223022815 |
UDI-Public | 14048223022815 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K911202 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
12/05/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/07/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 03/27/2022 |
Device Model Number | 141251-27A |
Device Catalogue Number | 141251-27A |
Device Lot Number | 1199 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/08/2017 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 10/18/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/28/2017 |
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;
|
|
|