MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-11 for PRESTIGE 8364-21 * manufactured by Covidien.
[3020381]
This happened to the scrub nurse not the patient. There was no patient harm. The maryland dissector was connected to the cautery unit and was being held by the scrub nurse. The covering on the handle had a small tear that exposed the bare metal. When the cautery was turned on the exposed metal made contact with the nurse's gown that was covering her upper arm and burned a hole in the gown causing a small burn to her skin. The staff member required neosporin ointment. The burn area was just slightly red. The esu was set at 35/35. No other device information is available. Our facility has had no other issues with the device. Staff believe this may have occurred due to the age of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2809291 |
| MDR Report Key | 2809291 |
| Date Received | 2012-10-11 |
| Date of Report | 2012-10-11 |
| Date of Event | 2012-10-05 |
| Report Date | 2012-10-11 |
| Date Reported to FDA | 2012-10-11 |
| Date Added to Maude | 2012-10-31 |
| 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 | PRESTIGE |
| Generic Name | DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDI |
| Date Received | 2012-10-11 |
| Model Number | 8364-21 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-11 |