Brand Name | SONOTAP |
Type of Device | ANAESTHESIA CONDUCTION NEEDLE, PERIPHERAL, SINGLE-SHOT |
Manufacturer (Section D) |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
karl-hall-str. 1 |
geisingen, baden-wuerttemberg 78187 |
GM 78187 |
|
MDR Report Key | 7111801 |
MDR Text Key | 95073434 |
Report Number | 9611612-2017-00020 |
Device Sequence Number | 1 |
Product Code |
BSP
|
UDI-Device Identifier | 14048223019761 |
UDI-Public | 14048223019761 |
Combination Product (y/n) | N |
PMA/PMN Number | K113207 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Type of Report
| Initial,Followup |
Report Date |
01/30/2018 |
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 |
Physician
|
Device Expiration Date | 07/31/2022 |
Device Model Number | 1185-3E080 |
Device Catalogue Number | 1185-3E080 |
Device Lot Number | 1217 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/10/2018 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/05/2017
|
Initial Date FDA Received | 12/13/2017 |
Supplement Dates Manufacturer Received | 12/05/2017
|
Supplement Dates FDA Received | 01/30/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|