MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-04 for PHOTOTHERAPY BOOTH 42UVB manufactured by Derma Control, Inc..
[19793]
Pt receiving phototherapy sustained second degree burns to lower extremity due to timer malfunction. Pt sustained no residual effects and had a full recovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008052 |
| MDR Report Key | 29236 |
| Date Received | 1996-01-04 |
| Date of Report | 1995-09-21 |
| Date of Event | 1995-08-14 |
| Date Added to Maude | 1996-01-11 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | PHOTOTHERAPY BOOTH |
| Generic Name | PHOTOTHERAPY BOOTH |
| Product Code | KGL |
| Date Received | 1996-01-04 |
| Model Number | 42UVB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30258 |
| Manufacturer | DERMA CONTROL, INC. |
| Manufacturer Address | PO BOX 667 FRANKFORT IL 60423 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-01-04 |