Brand Name | ACTIVELIFE 1-PIECE PRE-CUT DRAINABLE POUCH W/D |
Type of Device | POUCH, COLOSTOMY |
Manufacturer (Section D) |
CONVATEC DOMINICAN REPUBLIC, INC. |
san cristobal, haina |
DR |
|
Manufacturer Contact |
matthew
walenciak, dir
|
211 american ave |
greensboro, NC 27409
|
9083779293
|
|
MDR Report Key | 4059279 |
MDR Text Key | 19087320 |
Report Number | 9618003-2014-10424 |
Device Sequence Number | 1 |
Product Code |
EZQ
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K780454 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Consumer,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/04/2012 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/18/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | 022767 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 01/04/2012 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|