Brand Name | UNOMETER SAFETI+,150CM,2L,RH |
Type of Device | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE |
Manufacturer (Section D) |
UNOMEDICAL LTD. |
zavodskaya street |
50 fanipol dzerzhinsk district |
minsk region, minskaya voblast 22275 0 |
BO 222750 |
|
Manufacturer Contact |
jeanette
johnson
|
7900 triad center drive |
suite 400 |
greensboro, NC 27409
|
3365424681
|
|
MDR Report Key | 5984230 |
MDR Text Key | 55885531 |
Report Number | 3007966929-2016-00086 |
Device Sequence Number | 1 |
Product Code |
FFG
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
09/08/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/28/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 158101310190 |
Device Lot Number | 223486 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 10/06/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|