MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-09 for CODMAN & SHURTLEFF 243032 * manufactured by Codman & Shurtleff.
[19076406]
Transilluminator used on a premature infant to visualize veins for iv insertion. Wand of the transilluminator not in place while being used. Causing blister formation on infant's right hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023367 |
| MDR Report Key | 360010 |
| Date Received | 2001-11-09 |
| Date of Report | 2001-10-23 |
| Date of Event | 2001-10-17 |
| Date Added to Maude | 2001-11-16 |
| 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 | CODMAN & SHURTLEFF |
| Generic Name | TRANSILLUMINATOR |
| Product Code | FTF |
| Date Received | 2001-11-09 |
| Model Number | 243032 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 349192 |
| Manufacturer | CODMAN & SHURTLEFF |
| Manufacturer Address | NEW BEDFORD INDUSTRIAL PARK NEW BEDFORD MA 02745 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-11-09 |