FDA Adverse Event
Injury
Summary report: N
GIRAFFE MULTI - PURPOSE LAMP
MDR report key: 76221
·
Received March 12, 1997
Report
- Report Number
- 76221
- Event Type
- Injury
- Date Received
- March 12, 1997
- Date of Event
- March 6, 1997
- Report Date
- March 12, 1997
- Manufacturer
- GOODWIN MANUFACTURING
- Product Code
- GBC
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
HALOGEN INCANDESCENT LAMP WAS USED TO ILLUMINATE THE FIELD FOR REPAIR OF A PERINEAL LACERATION FOLLOWING DELIVERY OF AN INFANT. THE MOTHER WAS ANESTHETIZED FOR THE DELIVERY AND REPAIR WITH EPIDURAL ANESTHESIA. HER THIGH WAS BURNED BY THE LAMP: A 2ND DEGREE BURN OCCURRED WHICH REQUIRED ADD'L TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIRAFFE MULTI - PURPOSE LAMP | MULTI - PURPOSE LAMP | GBC | GOODWIN MANUFACTURING | 1183 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |