Brand Name | SPROTTE |
Type of Device | SPINAL NEEDLE, SINGLE USE |
Manufacturer (Section D) |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
karl-hall-str. 1 |
tuttlinger str. 7 |
geisingen, 78187 |
GM 78187 |
|
Manufacturer (Section G) |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
karl-hall-str. 1 |
tuttlinger str. 7 |
geisingen, 78187 |
GM
78187
|
|
Manufacturer Contact |
christian
quass
|
karl-hall-str. 1 |
tuttlinger str. 7 |
geisingen, 78187
|
GM
78187
|
|
MDR Report Key | 13166895 |
MDR Text Key | 286677050 |
Report Number | 9611612-2022-00001 |
Device Sequence Number | 1 |
Product Code |
BSP
|
UDI-Device Identifier | 04048223108611 |
UDI-Public | 04048223108611 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K911260 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
01/04/2022 |
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 Model Number | 321151-31A |
Device Catalogue Number | 321151-31A |
Device Lot Number | 1392 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/03/2022 |
Initial Date FDA Received | 01/05/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/06/2021 |
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) |
Required Intervention;
|
Patient Sex | Female |
|
|