Brand Name | ROTAREX®S 8F 110CM (STRAUB MEDICAL®) |
Type of Device | ATHERECTOMY CATHETER |
Manufacturer (Section D) |
STRAUB MEDICAL AG |
straubstrasse 12 |
wangs, sankt gallen 7323 |
SZ 7323 |
|
Manufacturer (Section G) |
STRAUB MEDICAL AG |
straubstrasse 12 |
|
wangs, sankt gallen 7323 |
SZ
7323
|
|
Manufacturer Contact |
martin
kvokacka
|
straubstrasse 12 |
wangs, sankt gallen 7323
|
SZ
7323
|
|
MDR Report Key | 11678680 |
MDR Text Key | 245816303 |
Report Number | 3008439199-2021-00030 |
Device Sequence Number | 1 |
Product Code |
MCW
|
UDI-Device Identifier | 07640142810391 |
UDI-Public | 7640142810391 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K172315 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/19/2021 |
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 | 11/09/2023 |
Device Model Number | SET ROTAREX®S 8F X 110CM |
Device Catalogue Number | 80224 |
Device Lot Number | 201554 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/23/2021 |
Initial Date Manufacturer Received |
03/19/2021 |
Initial Date FDA Received | 04/16/2021 |
Supplement Dates Manufacturer Received | 03/19/2021
|
Supplement Dates FDA Received | 12/18/2021
|
Was Device Evaluated by Manufacturer? |
Yes
|
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) |
Hospitalization;
Required Intervention;
|