Brand Name | TEMP PACING WIRE 24"(60CM) 2-0 LT/DK BLU |
Type of Device | ELECTRODE, PACEMAKER, TEMP |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 0151 |
|
MDR Report Key | 8478995 |
MDR Text Key | 141208414 |
Report Number | 2210968-2019-79966 |
Device Sequence Number | 1 |
Product Code |
LDF
|
UDI-Device Identifier | 10705031050891 |
UDI-Public | 10705031050891 |
Combination Product (y/n) | N |
PMA/PMN Number | K980503 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Type of Report
| Initial,Followup |
Report Date |
03/08/2019 |
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 |
No Information
|
Device Expiration Date | 06/30/2023 |
Device Catalogue Number | TPW32 |
Device Lot Number | MHH439 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/08/2019 |
Initial Date FDA Received | 04/03/2019 |
Supplement Dates Manufacturer Received | 03/08/2019
|
Supplement Dates FDA Received | 04/08/2019
|
Patient Sequence Number | 1 |
|
|