MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-12 for HIGH INTENSITY UVA-1 ML 24000 manufactured by Daavlin.
[38538476]
While pt was receiving uva-1 treatment, the glass filter on the back lower right column shattered. The shattering noise was very loud. Glass shards were mostly contained by the plastic shield, however, some glass shards did fall into the cabinet area. No glass shards reached the pt. The filters should last 1000 hours. The one involved was only at 72 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060274 |
| MDR Report Key | 5445269 |
| Date Received | 2016-02-12 |
| Date of Report | 2016-02-12 |
| Date of Event | 2016-01-22 |
| Date Added to Maude | 2016-02-18 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HIGH INTENSITY UVA-1 |
| Generic Name | HIGH INTENSITY UVA-1 |
| Product Code | FTC |
| Date Received | 2016-02-12 |
| Model Number | ML 24000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAAVLIN |
| Manufacturer Address | BRYAN OH 43506 US 43506 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-12 |