Brand Name | COLODRESS+ PCH CLD STD TAN 38MM |
Type of Device | POUCH, COLOSTOMY |
Manufacturer (Section D) |
CONVATEC DOM. REPUBLIC |
inc.: carr. sanchez, km. 18.5 |
parque industrial, haina |
san cristobal, 33102 |
DR 33102 |
|
Manufacturer Contact |
jeanette
johnson
|
211 american ave |
greensboro, NC 27409
|
3362973009
|
|
MDR Report Key | 5153708 |
MDR Text Key | 28414712 |
Report Number | 9618003-2015-30561 |
Device Sequence Number | 1 |
Product Code |
EZQ
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other
|
Report Date |
02/27/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 08/03/2018 |
Device Model Number | 403816 |
Device Lot Number | 3H02780 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/15/2014 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/15/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/04/2013 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|