Brand Name | DISPOSABLE GROUNDING PAD W/CABLE |
Type of Device | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. (AF-MINNETONKA) |
14901 deveau place |
minnetonka MN 55345 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, INC. (AF-MINNETONKA) |
14901 deveau place |
|
minnetonka MN 55345 |
|
Manufacturer Contact |
ronnie
shalev
|
6901 preston road |
plano, TX 75024
|
9723098000
|
|
MDR Report Key | 15735451 |
MDR Text Key | 303080632 |
Report Number | 2182269-2022-00054 |
Device Sequence Number | 1 |
Product Code |
GEI
|
UDI-Device Identifier | 05415067023629 |
UDI-Public | 05415067023629 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K111576 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
12/09/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/14/2024 |
Device Model Number | RF-DGP-S |
Device Catalogue Number | RF-DGP-S |
Device Lot Number | 20220315 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/07/2022 |
Initial Date FDA Received | 11/04/2022 |
Supplement Dates Manufacturer Received | 12/01/2022
|
Supplement Dates FDA Received | 12/09/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/15/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|