Brand Name | S2S/ SURFIT NATURA 2 PC-2PC DRAINABLE POUCH W/FILTER W/INVISICLOSE |
Manufacturer (Section D) |
CONVATEC DOMINICAN REPUBLIC, INC. |
carretera sanchez, km. 18.5 |
parque industrial itabo, s.a. |
san cristobal, haina |
DR |
|
Manufacturer Contact |
matthew
walenciak, dir. post mkt
|
211 american avenue |
greensboro, NC 27409
|
9083779293
|
|
MDR Report Key | 4095973 |
MDR Text Key | 4713465 |
Report Number | 9618003-2014-11242 |
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 |
01/07/2013 |
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 Expiration Date | 08/09/2017 |
Device Model Number | 411310 |
Device Lot Number | 2H00995 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/07/2013
|
Initial Date FDA Received | 09/08/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/01/2012 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Weight | 54 |
|
|