Brand Name | ELECTRODES, FETAL SCALP (FSE), 50/CASE |
Type of Device | ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR |
Manufacturer (Section D) |
PRECISION CONCEPTS COSTA RICA SA |
saret industrial park building |
alajuela |
rio segundo 74-4002 |
CS |
|
Manufacturer (Section G) |
PRECISION CONCEPTS COSTA RICA SA |
saret industrial park building |
alajuela |
rio segundo 74-4002 |
CS
|
|
Manufacturer Contact |
avery
foster
|
22745 savi ranch parkway |
yorba linda, CA 92887
|
|
MDR Report Key | 7540145 |
MDR Text Key | 109113348 |
Report Number | 2050001-2018-00108 |
Device Sequence Number | 1 |
Product Code |
HGP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K792669 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
05/24/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 7000AAO |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/14/2018 |
Initial Date FDA Received | 05/24/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|