Brand Name | SPROTTE 2G |
Type of Device | ANAESTHESIA CONDUCTION NEEDLE, SPINAL, SINGLE SHOT |
Manufacturer (Section D) |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
karl-hall-str. 1 |
tuttlinger str. 7 |
geisingen, baden-wuerttemberg 78187 |
GM 78187 |
|
MDR Report Key | 8099227 |
MDR Text Key | 128587919 |
Report Number | 9611612-2018-00043 |
Device Sequence Number | 1 |
Product Code |
BSP
|
UDI-Device Identifier | 14048223024307 |
UDI-Public | 14048223024307 |
Combination Product (y/n) | N |
PMA/PMN Number | K911202 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Type of Report
| Initial,Followup |
Report Date |
12/19/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/23/2023 |
Device Model Number | 021251-29A |
Device Catalogue Number | 021251-29A |
Device Lot Number | 1264 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/20/2018 |
Initial Date FDA Received | 11/23/2018 |
Supplement Dates Manufacturer Received | 11/20/2018
|
Supplement Dates FDA Received | 12/19/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|