MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-27 for DISPOSABLE GROUNDING PAD WITH CABLE manufactured by St. Jude Medical Inc..
[106785654]
Patient Sequence No: 1, Text Type: N, H10
[106785655]
Patient was admitted for a radiofrequency ablation of his thoracic nerves. Prior to the procedure, a grounding pad was placed on his right flank. The integrity of the pad was assessed prior to placement as well as before each ablation. The skin prior to the ablations was clean dry and intact. There was complete contact of the grounding pad with the patient's skin. There was no excessive hair over the area of the grounding pad. After the procedure was completed, the grounding pad was removed. It was at this time that 3 small red areas with a beige center were discovered. The doctor was notified and came to see the areas. The trauma burn clinic was notified. The patient has an appointment to follow-up with the doctor. Silvadene cream was ordered by the doctor and electronically sent to the patient's pharmacy. Instructions for use of the cream were explained to the patient. The radiofrequency ablation machine was sent to biomed for assessment/evaluation. All serial numbers for the probes have been documented and the probes will be assessed as well. Rfa machine, probes, grounding pad and needle cannula were saved and sent to bio-med. Company notified and all has been sent to st. Jude for review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7468436 |
| MDR Report Key | 7468436 |
| Date Received | 2018-04-27 |
| Date of Report | 2018-03-27 |
| Date of Event | 2018-02-28 |
| Report Date | 2018-03-27 |
| Date Reported to FDA | 2018-03-27 |
| Date Reported to Mfgr | 2018-03-27 |
| Date Added to Maude | 2018-04-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE GROUNDING PAD WITH CABLE |
| Generic Name | STIMULATORS-AUTOMATIC NERVE |
| Product Code | JOS |
| Date Received | 2018-04-27 |
| Lot Number | 20170625 |
| ID Number | SN50275, SN48828,SN46468, LO |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL INC. |
| Manufacturer Address | 6901 PRESTON ROAD PLANO TX 75024 US 75024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-27 |