Brand Name | FLOOR SENSOR |
Manufacturer (Section D) |
J. T. POSEY CO. |
arcadia CA |
|
Manufacturer (Section G) |
POSEY, S. DE R.L. DE C.V. |
ave ferrocarril no 16901 bodega 64 |
|
colonia rio tijuana, 3ra etapa tijuana 2266 4 |
MX
22664
|
|
Manufacturer Contact |
roxana
koussa
|
5635 peck rd. |
arcadia, CA 91006
|
6264433143
|
|
MDR Report Key | 4450140 |
MDR Text Key | 5393077 |
Report Number | 2020362-2015-00015 |
Device Sequence Number | 1 |
Product Code |
KMI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Unknown
|
Type of Report
| Initial |
Report Date |
12/23/2014 |
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 |
Health Professional
|
Device Model Number | 8250S |
Device Catalogue Number | 8250S |
Device Lot Number | 4289T078 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 12/31/2014 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/23/2014 |
Initial Date FDA Received | 01/16/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/01/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Treatment | KEEPSAFE FALL ALARM (PART #8350), LOT UNK |
|
|