Brand Name | BULKAMID URETHRAL BULKING SYSTEM |
Type of Device | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Manufacturer (Section D) |
AXONICS, INC |
26 technology dr |
irvine CA 92618 |
|
Manufacturer (Section G) |
CONTURA INTERNATIONA A/S |
23 sydmarken |
|
soeborg |
DK
|
|
Manufacturer Contact |
james
nguyen
|
26 technology drive |
irvine, CA 92618
|
|
MDR Report Key | 18727882 |
MDR Text Key | 335709160 |
Report Number | 3002968685-2024-00021 |
Device Sequence Number | 1 |
Product Code |
LNM
|
Combination Product (y/n) | N |
PMA/PMN Number | P170023 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/16/2024 |
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? |
No
|
Device Model Number | 50012 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/22/2024 |
Initial Date FDA Received | 02/16/2024 |
Was Device Evaluated by Manufacturer? |
No
|
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 |