Brand Name | C BNFM 14X5/15 SIL SUP |
Type of Device | CATHETER, RETENTION TYPE, BALLOON |
Manufacturer (Section D) |
UNOMEDICAL SDN BHD |
bakar arang industrial estate |
sungai petani |
kedah, 08000 |
MY 08000 |
|
Manufacturer Contact |
jeanette
johnson
|
7900 triad center drive |
greensboro, NC 27409
|
3365424681
|
|
MDR Report Key | 5289557 |
MDR Text Key | 33279447 |
Report Number | 9611710-2015-40054 |
Device Sequence Number | 1 |
Product Code |
EZL
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K770256 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/06/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/11/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | HA31141002 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/13/2012 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 11/06/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
|
|