Brand Name | S4S/SUR-FIT NATURA 2PC-2PC CLOSED END POUCH W/FILTER |
Type of Device | POUCH, COLOSTOMY |
Manufacturer (Section D) |
CONVATEC DOM. REPUBLIC INC. |
carr sanche, km 18.5 |
parque industrial |
haina, san cristobal 3310 2 |
DR 33102 |
|
Manufacturer Contact |
matthew
walenciak, dir
|
211 american avenue |
greensboro, NC 27409
|
9083779293
|
|
MDR Report Key | 4135780 |
MDR Text Key | 4927833 |
Report Number | 9618003-2014-11709 |
Device Sequence Number | 1 |
Product Code |
EZQ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K840568 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Consumer,Company Representative |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
06/10/2013 |
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 Model Number | 413174 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/10/2013
|
Initial Date FDA Received | 09/29/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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;
|
|
|