Brand Name | NATURA® MOLDABLE STOMAHESIVE® SKIN BARRIER |
Type of Device | PROTECTOR, OSTOMY |
Manufacturer (Section D) |
CONVATEC, INC. |
211 american avenue |
greensboro, NC 27409 |
|
Manufacturer Contact |
jeanette
johnson
|
7900 triad center drive |
suite 400 |
greensboro, NC 27409
|
3365424681
|
|
MDR Report Key | 6103345 |
MDR Text Key | 59972466 |
Report Number | 1049092-2016-00472 |
Device Sequence Number | 1 |
Product Code |
EXE
|
Combination Product (y/n) | N |
Reporter Country Code | NO |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/26/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/15/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 03/31/2016 |
Device Model Number | 411805 |
Device Lot Number | 6C03457 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/07/2016 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 10/26/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/05/2016 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|