Brand Name | ATR.VASCULAR CLIP 25MM CVD.3.43N ARTERI. |
Type of Device | CLAMP, VASCULAR |
Manufacturer (Section D) |
AESCULAP AG |
po box 40 |
tuttlingen, 78501 |
GM 78501 |
|
Manufacturer (Section G) |
AESCULAP AG |
po box 40 |
|
tuttlingen, 78501 |
GM
78501
|
|
Manufacturer Contact |
christian
von der grün
|
po box 40 |
tuttlingen, 78501
|
GM
78501
|
|
MDR Report Key | 11518654 |
MDR Text Key | 254003893 |
Report Number | 9610612-2021-00179 |
Device Sequence Number | 1 |
Product Code |
DXC
|
UDI-Device Identifier | 04046963094089 |
UDI-Public | 4046963094089 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K992053 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/20/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/18/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | PL548S |
Device Catalogue Number | PL548S |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/03/2021 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/26/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/01/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|