MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-10 for VENOSCOPE II NEONATAL TRANSILLUMINATOR KT01 * manufactured by Venoscope, Llc.
[15558856]
Pt needed iv started. Venoscope ii neonatal transilluminator used to aid site slection. Transilluminator off for most of the time during site selection. Nurse checked temperature of light on transilluminator several times; light not hot. However, light was held in place for 2 minutes during procedure. After task completed, an open and slightly weeping area noted in forearm with scant fluid and mild edema.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037150 |
| MDR Report Key | 747263 |
| Date Received | 2005-11-10 |
| Date of Report | 2005-11-10 |
| Date of Event | 2005-11-02 |
| Date Added to Maude | 2006-08-15 |
| 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 | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | VENOSCOPE II NEONATAL TRANSILLUMINATOR |
| Generic Name | NEONATAL TRANSILLUMINATOR |
| Product Code | HJN |
| Date Received | 2005-11-10 |
| Model Number | KT01 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 735038 |
| Manufacturer | VENOSCOPE, LLC |
| Manufacturer Address | P.O. BOX 52703 LAFAYETTE LA 70505 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-11-10 |