Brand Name | FOLYSIL CATHETER |
Type of Device | CATHETER, RETENTION TYPE, BALLOON |
Manufacturer (Section D) |
COLOPLAST A/S |
holtedam 1 |
humlebæk 3050 |
DA 3050 |
|
Manufacturer (Section G) |
COLOPLAST A/S MANUFACTURING |
9 avenue edmond rostand |
|
sarlat-la-caneda 24206 |
FR
24206
|
|
Manufacturer Contact |
usaby
angela kilian
|
1601 west river road north |
minneapolis, MN 55411
|
8007880293
|
|
MDR Report Key | 12661040 |
MDR Text Key | 277397490 |
Report Number | 9610711-2021-00089 |
Device Sequence Number | 1 |
Product Code |
EZL
|
UDI-Device Identifier | 03600040129975 |
UDI-Public | 03600040129975 |
Combination Product (y/n) | N |
PMA/PMN Number | K013174 |
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 |
Report Date |
10/19/2021 |
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 Model Number | AA64161002 |
Device Catalogue Number | AA6416 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/08/2021 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/27/2021 |
Initial Date FDA Received | 10/19/2021 |
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 |