Brand Name | SUR-FIT NATURA 2PC UROSTOMY POUCH W/ ACCUSEAL |
Type of Device | URINARY, ILEOSTOMY |
Manufacturer (Section D) |
CONVATEC DOMINICAN REPUBLIC, INC. |
carretera sanchez, km. 18.2 |
parque industrial itabo, s.a. |
san cristobal, haina 3310 2 |
DR 33102 |
|
Manufacturer Contact |
mary
szaro, assoc, dir.
|
200 headquarters park drive |
skillman, NJ 08558
|
9089042450
|
|
MDR Report Key | 3670285 |
MDR Text Key | 4343065 |
Report Number | 9618003-2014-00012 |
Device Sequence Number | 1 |
Product Code |
EXH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K840166 |
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 |
12/20/2013 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 05/05/2018 |
Device Model Number | 401544 |
Device Catalogue Number | 401544 |
Device Lot Number | 3E02938 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/20/2013
|
Initial Date FDA Received | 01/15/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2013 |
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 |
|
|