MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-13 for BEAM THERAPY manufactured by Unknown.
[20991752]
A 69-yr-old male pt presented in 1/94 with cough, fevers, sweats, anorexia, and weight loss was started on prednisone for radiation pneumonia. Presented in february with doe, admitted to hosp 3/8/94, with severe doe, temps, sweats, and mouth soreness. Supportive care, antibiotic coverage, and steroids given. Pt had pneumocystis, herpes, and radiation pneumonia. 3/19, bilateral pneumothorax, 3/22, intubated; and on 3/25 pt expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000440 |
| MDR Report Key | 14883 |
| Date Received | 1994-07-13 |
| Date of Event | 1994-01-12 |
| Date Added to Maude | 1994-07-27 |
| 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 |
| 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 | BEAM THERAPY |
| Product Code | IWD |
| Date Received | 1994-07-13 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14877 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-07-13 |