MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-25 for CELSION APA 1000 4100145-1 manufactured by Celsion Corp.
[334245]
Pt is being treated on celsion protocol 201. Randomized to receive chemo and microwave thermotherapy. Pt. Received chemo with adriamycin/cytoxan in am. Had microwave thermotherapy that afternoon. 40 minutes into the treatment, pt c/o pain and burning sensation at the 6:00 axis in an area beneath the inframammary line above the ribcage. The skin in this area was warm to the touch. There was no obvious redness, pain in the treated left breast. The pt completed the entire treatment. Erythema noted post procedure in this area. The next day a thermal blister developed in the inframammary area left breast.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031658 |
| MDR Report Key | 519278 |
| Date Received | 2004-03-25 |
| Date of Report | 2004-03-23 |
| Date of Event | 2004-03-10 |
| Date Added to Maude | 2004-04-08 |
| 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 |
| 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 | CELSION |
| Generic Name | MICROWAVE THERMOTHERAPY |
| Product Code | LOC |
| Date Received | 2004-03-25 |
| Model Number | APA 1000 |
| Catalog Number | 4100145-1 |
| Lot Number | * |
| ID Number | AC-115VAC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 508337 |
| Manufacturer | CELSION CORP |
| Manufacturer Address | 10220 L OLD COLUMBIA ROAD COLUMBIA MD 210462364 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-03-25 |