MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-12 for ANODYNE LIGHT THERAPY UNK manufactured by Anodyne Light Therapy.
[5951165]
Went to (b)(6) ctr for anodyne light therapy treatment on (b)(6). Treatment was administered longer than protocol and skin condition was not checked every 10 minutes. Burns were noticed that evening with pain and extreme swelling. Went to er, (b)(6) emergency room in (b)(6) was treated for burns, pain, and swelling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042730 |
| MDR Report Key | 4777300 |
| Date Received | 2015-05-12 |
| Date of Report | 2015-05-12 |
| Date of Event | 2015-05-07 |
| Date Added to Maude | 2015-05-19 |
| 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 | PATIENT |
| Health Professional | 0 |
| 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 | ANODYNE LIGHT THERAPY |
| Generic Name | ANODYNE LIGHT THERAPY |
| Product Code | ILY |
| Date Received | 2015-05-12 |
| Model Number | UNK |
| Lot Number | UNK |
| Operator | OTHER |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANODYNE LIGHT THERAPY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-05-12 |