Brand Name | FETAL SPIRAL ELECTRODE |
Type of Device | FETAL SPIRAL ELECTRODE, SINGLE |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer Contact |
robert
corning
|
3000 minuteman road |
andover, MA 01810
|
9786871501
|
|
MDR Report Key | 8443379 |
MDR Text Key | 139679211 |
Report Number | 1218950-2019-02244 |
Device Sequence Number | 1 |
Product Code |
HGP
|
UDI-Device Identifier | 20884838007431 |
UDI-Public | (01)20884838007431 |
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K030691 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/13/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/22/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 989803137631 |
Device Catalogue Number | 989803137631 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 03/13/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|