Brand Name | ESTEEM ONE-PIECE CUT-TO-FIT POUCH WITH INVISICLOSE |
Type of Device | POUCH, COLOSTOMY |
Manufacturer (Section D) |
CONVATEC, PURCHASING DEPARTMENT |
7900 triad center drive |
suite 400 |
greensboro NC 27409 |
|
MDR Report Key | 8959632 |
MDR Text Key | 156438777 |
Report Number | 8959632 |
Device Sequence Number | 1 |
Product Code |
EZQ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/27/2019 |
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 |
No Information
|
Device Model Number | 416718 |
Device Catalogue Number | 416718 |
Device Lot Number | 9A02271 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/27/2019 |
Date Report to Manufacturer | 09/04/2019 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/04/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|