Brand Name | URINARY DRAINAGE BAGS |
Type of Device | BAG, URINARY, ILEOSTOMY |
Manufacturer (Section D) |
UNOMEDICAL S.R.O. |
priemyselny park 3 |
michalovce 07101 |
LO 07101 |
|
Manufacturer Contact |
matthew
walenciak, assoc, dir.
|
211 american avenue |
greensboro, NC 27409
|
9083779293
|
|
MDR Report Key | 3993953 |
MDR Text Key | 21173256 |
Report Number | 3005778470-2014-00048 |
Device Sequence Number | 1 |
Product Code |
EXH
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/26/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/24/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 38 162 1S-20 |
Device Catalogue Number | 38 162 1S-20 |
Device Lot Number | 494028 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/26/2014 |
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 |
|
|