FDA Adverse Event
Malfunction
Summary report: N
SNOWDEN PENCER RIGHT ANGLE LIGHTED
MDR report key: 3786122
·
Received April 25, 2014
Report
- Report Number
- 3786122
- Event Type
- Malfunction
- Date Received
- April 25, 2014
- Date of Event
- February 13, 2014
- Report Date
- April 25, 2014
- Manufacturer
- CAREFUSION 2200 INC
- Product Code
- GAD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
SURGEON REQUESTED LIGHTED RETRACTOR DURING THE SURGERY. PHYSICIAN PERFORMING SUBSEQUENT RECONSTRUCTION SURGERY NOTICED BLISTER ON PATIENT'S RIGHT CHEST THAT MAY BE A BURN. ORDERED SILVADENE CREAM POSTOP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251885 | SNOWDEN PENCER RIGHT ANGLE LIGHTED | RETRACTOR, FIBEROPTIC | GAD | CAREFUSION 2200 INC | * | * | |
| 251886 | CIRCON | LIGHT, SURGICAL, CARRIER | GAD | GYRUS ACMI, INC | G93 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |