MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-21 for VITAL VUE * manufactured by Covidien.
[1713387]
Patient was having a laparoscopically assisted vaginal hysterectomy (lavh). At the conclusion of the vaginal portion of the procedure, the surgeon placed the vital vue on the patient's abdomen. The surgeon inspected the abdominal cavity laparoscopically and began to close the abdominal incision. The operating room nurse then started to remove equipment off of field. The nurse disconnected the vital vue from the fluid and power source. Once the incisions were closed and dressed, the surgical drapes were removed. At that time there was a blistered, white area approximately 1 inch by 2 inches on the upper left thigh near the groin. Silvadene cream was ordered for application.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2000543 |
| MDR Report Key | 2000543 |
| Date Received | 2011-02-21 |
| Date of Report | 2011-02-21 |
| Date of Event | 2011-01-25 |
| Report Date | 2011-02-21 |
| Date Reported to FDA | 2011-02-21 |
| Date Added to Maude | 2011-02-24 |
| 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 | VITAL VUE |
| Generic Name | VITAL VUE |
| Product Code | HBI |
| Date Received | 2011-02-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 0273053 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 6135 GUNBARREL AVE. BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-21 |