Brand Name | ACTIVELIFE 1PC DRAINABLE POUCH W/STOMAHESIVE |
Type of Device | POUCH, COLOSTOMY |
Manufacturer (Section D) |
CONVATEC DOMINICAN REPUBLIC, INC. |
carretera sanchez, km. 18.2 |
parque industrial itabo, s.a. |
san cristobal, haina |
DR |
|
Manufacturer (Section G) |
CONVATEC DOMINICAN REPUBLIC, INC. |
carretera sanchez, km. 18.2 |
parque industrial itabo, s.a. |
san cristobal, haina |
DR
|
|
Manufacturer Contact |
david
gray
|
200 headquarters park drive |
skillman, NJ 08558
|
9089042450
|
|
MDR Report Key | 3667059 |
MDR Text Key | 4319790 |
Report Number | 9618003-2014-00019 |
Device Sequence Number | 1 |
Product Code |
EZQ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K833625 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Company Representative |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
01/14/2014 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 02/18/2018 |
Device Model Number | 022771 |
Device Catalogue Number | 022771 |
Device Lot Number | 3B01609 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/14/2014 |
Initial Date FDA Received | 02/12/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/01/2013 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Weight | 66 |
|
|