MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-03 for XENON SERIES 900 9300 * manufactured by Luxtec.
[987169]
An infant with difficult iv access. Md used headlamp to transilluminate the hands. Post-operatively infant noted to have bilateral palm blisters. One of the blisters was broken. Both hands were dressed with silvadene and gauze. Unknown healing outcome as the infant had no further care at the institution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1233003 |
| MDR Report Key | 1233003 |
| Date Received | 2008-11-03 |
| Date of Report | 2008-11-03 |
| Date of Event | 2008-09-02 |
| Report Date | 2008-11-03 |
| Date Reported to FDA | 2008-11-03 |
| Date Added to Maude | 2008-11-18 |
| 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 | XENON SERIES 900 |
| Generic Name | SURGICAL HEADLAMP |
| Product Code | HBI |
| Date Received | 2008-11-03 |
| Model Number | 9300 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1284320 |
| Manufacturer | LUXTEC |
| Manufacturer Address | 99 HARTWELL ST WEST BOYLSTON MA 01583 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-03 |