Brand Name | IMAJIN DOUBLE LOOP URETERAL STENT KIT IN SILICONE |
Type of Device | UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE |
Manufacturer (Section D) |
COLOPLAST A/S |
1 holtedam humlebaek, dk 3050 |
humlebaek 3050 |
DA 3050 |
|
Manufacturer (Section G) |
CMF-SARLAT |
9 avenue edmond rostand |
|
sarlat-la-caneda |
FR
|
|
Manufacturer Contact |
usbes
brian schmidt
|
1601 west river road n |
minneapolis, MN 55411
|
|
MDR Report Key | 18110597 |
MDR Text Key | 328062245 |
Report Number | 9610711-2023-00242 |
Device Sequence Number | 1 |
Product Code |
FAD
|
UDI-Device Identifier | 03600040203453 |
UDI-Public | 3600040203453 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K213185 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/21/2024 |
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 | AJ4U85 |
Device Lot Number | 9320415_AJ4U851002 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 11/10/2023 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/21/2024
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 08/07/2023 |
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 |