MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-24 for OHMEDA PHOTOTHERAPY LIGHT * manufactured by Ohmeda Medical, (part Of Ge Medical Systems).
[341628]
A 1 1/2 x 1/2 cm dark red area was noted on abdomen. The pt was on triple phototherapy with blanket, overhead and spotlight. The spotlight was discontinued. Cool compresses were ordered and applied, and periodically reapplied to the excoriated area on the abdomen until discharge. The light was sent to biomedical engineering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 502715 |
| MDR Report Key | 502715 |
| Date Received | 2003-12-24 |
| Date of Report | 2003-10-01 |
| Date of Event | 2003-09-01 |
| Date Added to Maude | 2003-12-29 |
| 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 | 3 |
| 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 | OHMEDA PHOTOTHERAPY LIGHT |
| Generic Name | PHOTOTHERAPY LIGHT |
| Product Code | KGL |
| Date Received | 2003-12-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 491488 |
| Manufacturer | OHMEDA MEDICAL, (PART OF GE MEDICAL SYSTEMS) |
| Manufacturer Address | 8880 GORMAN ROAD LAUREL MD 20723 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-12-24 |