Brand Name | MX40 2.4 GHZ SMART HOPPING |
Type of Device | MX40 2.4 GHZ SMART HOPPING |
Manufacturer (Section D) |
PHILIPS NORTH AMERICA LLC |
3000 minuteman road |
andover MA 01810 |
|
MDR Report Key | 11609546 |
MDR Text Key | 243637276 |
Report Number | 1218950-2021-10268 |
Device Sequence Number | 1 |
Product Code |
DSI
|
UDI-Device Identifier | 00884838082243 |
UDI-Public | 00884838082243 |
Combination Product (y/n) | N |
PMA/PMN Number | K113125 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial,Followup |
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 | 865351 |
Device Catalogue Number | 865351 |
Was Device Available for Evaluation? |
No
|
Distributor Facility Aware Date | 03/17/2021 |
Initial Date Manufacturer Received |
03/17/2021
|
Initial Date FDA Received | 04/02/2021 |
Supplement Dates Manufacturer Received | 03/17/2021
|
Supplement Dates FDA Received | 06/21/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|