Brand Name | TPW 2X24IN 2-0 D/A SH,SKS-3 BWY |
Type of Device | ELECTRODE, PACEMAKER, TEMP |
Manufacturer (Section D) |
ETHICON INC. |
1000 route 202 |
raritan NJ 08869 |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
elba
bello
|
1000 route 202 |
raritan, NJ 08869
|
|
MDR Report Key | 12238809 |
MDR Text Key | 265873298 |
Report Number | 2210968-2021-06759 |
Device Sequence Number | 1 |
Product Code |
LDF
|
UDI-Device Identifier | 10705031050891 |
UDI-Public | 10705031050891 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K980503 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/30/2021 |
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 | TPW32 |
Device Catalogue Number | TPW32 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/30/2021
|
Initial Date FDA Received | 07/28/2021 |
Supplement Dates Manufacturer Received | 08/10/2021
|
Supplement Dates FDA Received | 08/10/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|