Brand Name | 2-WAY, HARD VALVE, STANDARD TIP, 5/10CC, CH12 |
Type of Device | CATHETER, RETENTION TYPE, BALLOON |
Manufacturer (Section D) |
UNOMEDICAL SDN BHD |
bakar arang ind estate |
sungai petani |
kedah, 08000 |
MY 08000 |
|
Manufacturer Contact |
jeanette
johnson
|
211 american ave |
greensboro, NC 27409
|
3362973009
|
|
MDR Report Key | 5188641 |
MDR Text Key | 29866240 |
Report Number | 9611710-2015-31121 |
Device Sequence Number | 1 |
Product Code |
EZL
|
Combination Product (y/n) | N |
Reporter Country Code | SW |
PMA/PMN Number | K770256 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/27/2014 |
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 |
No Information
|
Device Model Number | MM51161210 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/27/2014
|
Initial Date FDA Received | 10/29/2015 |
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 |
|
|