MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-30 for COOLSPOT SINGLE CEILING CS316SC NA manufactured by Burton Medical Products.
[1438877]
The light fell from it's ceiling mount as it was being moved while in use with a pt. The nurse in attendance pushed the pt out of the path of the falling light. In doing so, he was struck in the head by the light. The impact was sufficient to break the skin, however, no treatment (such as stitches) was required. The nurse expressed no further complaints subsequent to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015355 |
| MDR Report Key | 1649719 |
| Date Received | 2010-03-30 |
| Date of Report | 2010-03-19 |
| Date of Event | 2010-03-05 |
| Date Added to Maude | 2010-04-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOLSPOT SINGLE CEILING |
| Generic Name | LUMINARY |
| Product Code | FCQ |
| Date Received | 2010-03-30 |
| Model Number | CS316SC |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BURTON MEDICAL PRODUCTS |
| Manufacturer Address | CHATSWORTH CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-30 |