MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-19 for FIBEROPTIC TRANSILLUMINATOR manufactured by Luxtec Corp..
[18546]
Transilluminator being used on premature neonate for iv placement. Burn resulted due to apparent mixup of electrical cables (gray cable attached instead of appropriate white cable. Age at time of event: 7 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009530 |
| MDR Report Key | 34287 |
| Date Received | 1996-07-19 |
| Date of Report | 1996-07-01 |
| Date of Event | 1996-05-17 |
| Date Added to Maude | 1996-07-23 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIBEROPTIC TRANSILLUMINATOR |
| Generic Name | FIBEROPTIC TRANSILLUMINATOR |
| Product Code | MQW |
| Date Received | 1996-07-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35647 |
| Manufacturer | LUXTEC CORP. |
| Manufacturer Address | 326 CLARK ST WORCESTER MA 01606 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-07-19 |