MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-12 for GIRAFFE MULTI - PURPOSE LAMP 1183 * manufactured by Goodwin Manufacturing.
[44182]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 76221 |
| MDR Report Key | 76221 |
| Date Received | 1997-03-12 |
| Date of Report | 1997-03-12 |
| Date of Event | 1997-03-06 |
| Date Facility Aware | 1997-03-07 |
| Report Date | 1997-03-12 |
| Date Added to Maude | 1997-03-18 |
| 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 | GIRAFFE MULTI - PURPOSE LAMP |
| Generic Name | MULTI - PURPOSE LAMP |
| Product Code | GBC |
| Date Received | 1997-03-12 |
| Model Number | 1183 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 75966 |
| Manufacturer | GOODWIN MANUFACTURING |
| Manufacturer Address | 241 MAIN ST PO BOX 378 LUCK WI 54853 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-03-12 |