Brand Name | HS1 ADULT SMART PADS CARTRIDGE |
Type of Device | PADS |
Manufacturer (Section D) |
PHILIPS NORTH AMERICA LLC |
22100 bothell everett highway |
bothell WA 98021 |
|
Manufacturer (Section G) |
PHILIPS NORTH AMERICA LLC |
22100 bothell everett highway |
|
bothell WA 98021 |
|
Manufacturer Contact |
bethany
glynn
|
22100 bothell everett highway |
bothell, WA 98021
|
9095703538
|
|
MDR Report Key | 14288223 |
MDR Text Key | 290799813 |
Report Number | 3030677-2022-02388 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | P160029 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
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 |
Other
|
Device Expiration Date | 04/08/2022 |
Device Catalogue Number | M5071A |
Device Lot Number | Y100819-01 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/22/2022
|
Initial Date FDA Received | 05/05/2022 |
Supplement Dates Manufacturer Received | 05/11/2022
|
Supplement Dates FDA Received | 05/16/2022
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Removal/Correction Number | Z-0881-2022 |
Patient Sequence Number | 1 |
|
|