MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-03-02 for VITAL VUE LIGHT POWER SOURCE (110V) 8886828401 manufactured by Nellcor Puritan Bennett.
[1913885]
Procedure type: laparoscopically assisted vaginal hysterectomy. According to the reporter: at the conclusion of the vaginal portion of the procedure, the vitual vue was apparently placed on the pt's abdomen by the surgical team. They inspected the abdominal cavity laparoscopically and began to close the pt. I disconnected the vital vue from the fluid and the electrical source as part of the initial clean up procedure. Once the incisions were closed and dressed, the drapes were moved. At that time, dr (b)(6) and i noticed a blistered, white area approx 1 in by 2 inches on the pt's upper left thigh near the groin. Dr (b)(6) was present and inspected the area. Silvadene cream was ordered for application in the eight floor pacu as the pt was prepared for transport.
Patient Sequence No: 1, Text Type: D, B5
[9164362]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610849-2011-00005 |
| MDR Report Key | 2015706 |
| Report Source | 05,06 |
| Date Received | 2011-03-02 |
| Date of Report | 2011-02-15 |
| Date of Event | 2011-01-31 |
| Date Mfgr Received | 2011-02-15 |
| Date Added to Maude | 2011-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 60 MIDDLETOWN AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926273 |
| Manufacturer G1 | NELLCOR PURITAN BENNETT MEXICO, S.A. DE C.V. |
| Manufacturer Street | 37 BLVD. INSURGENTES, LIBRIAMENTO A LA P., LA MESA |
| Manufacturer City | TIJUANA, B.C. 92173 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL VUE LIGHT POWER SOURCE (110V) |
| Generic Name | SURGICAL LIGHT POWER SOURCE |
| Product Code | HBI |
| Date Received | 2011-03-02 |
| Catalog Number | 8886828401 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NELLCOR PURITAN BENNETT |
| Manufacturer Address | 37 BLVD. INSURGENTES TIJUANA, B.C. 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-02 |