Brand Name | X-FLOW PROSTATECTOMY CATHETER |
Type of Device | INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL |
Manufacturer (Section D) |
COLOPLAST A/S |
1 holtedam humlebaek, dk 3050 |
humlebaek 3050 |
DA 3050 |
|
Manufacturer Contact |
usbes
brian schmidt
|
1601 west river road n |
minneapolis, MN 55411
|
|
MDR Report Key | 19154594 |
MDR Text Key | 340735508 |
Report Number | 9610711-2024-00091 |
Device Sequence Number | 1 |
Product Code |
EZL
|
UDI-Device Identifier | 03600040144183 |
UDI-Public | 3600040144183 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/22/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | AB6318 |
Device Lot Number | 8931551_AB63181002 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/22/2024 |
Date Device Manufactured | 12/19/2022 |
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 |
|
|