MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-18 for EDGE COATED ELECTRODES * E1455 manufactured by Cardinal Health.
[3130802]
Physician using a valleylab edge coated electrode to perform a dissection through an inframmary approach. Physician noticed that the insulation was missing off the electrode. After looking for it, the physician discovered it had fallen off the electrode. The insulation was removed off the surgical field. Another electrode was obtained. The pectoral muscle was elevated and divided inferiorly completely and partially medially. A symmetrical dissection was performed on the other side through the same approach. Procedure completed without further complications. Patient taken to recovery room in stable condition. What was the original intended procedure? Bilateral breast augmentation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2989451 |
| MDR Report Key | 2989451 |
| Date Received | 2013-02-18 |
| Date of Report | 2013-02-18 |
| Date of Event | 2013-02-13 |
| Report Date | 2013-02-18 |
| Date Reported to FDA | 2013-02-18 |
| Date Reported to Mfgr | 2013-03-05 |
| Date Added to Maude | 2013-03-05 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDGE COATED ELECTRODES |
| Generic Name | ELECTRODE, ELECTROSURGICAL |
| Product Code | NWI |
| Date Received | 2013-02-18 |
| Model Number | * |
| Catalog Number | E1455 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD-MPKB-2B MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-18 |