MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-12 for DISPOSABLE GROUNDING PAD W/CABLE RF-DGP-S manufactured by St. Jude Medical, Inc..
Report Number | 2182269-2019-00237 |
MDR Report Key | 9310179 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2019-11-12 |
Date of Report | 2019-11-12 |
Date of Event | 2019-10-23 |
Date Mfgr Received | 2019-10-23 |
Device Manufacturer Date | 2018-12-25 |
Date Added to Maude | 2019-11-12 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 0 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | STEPHANIE O' SULLIVAN |
Manufacturer Street | 5050 NATHAN LANE NORTH |
Manufacturer City | PLYMOUTH MN 55442 |
Manufacturer Country | US |
Manufacturer Postal | 55442 |
Manufacturer Phone | 6517565400 |
Manufacturer G1 | ST. JUDE MEDICAL, INC. |
Manufacturer Street | 14901 DEVEAU PLACE |
Manufacturer City | MINNETONKA MN 55345 |
Manufacturer Country | US |
Manufacturer Postal Code | 55345 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | DISPOSABLE GROUNDING PAD W/CABLE |
Generic Name | DISPOSABLE GROUNDING PAD |
Product Code | GXD |
Date Received | 2019-11-12 |
Model Number | RF-DGP-S |
Lot Number | 20181225 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ST. JUDE MEDICAL, INC. |
Manufacturer Address | 14901 DEVEAU PLACE MINNETONKA MN 55345 US 55345 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-11-12 |