MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-28 for * 1924 manufactured by Nelco, Inc.
[16260833]
The sliding door for the radiation therapy treatment vault failed to open following a treatment session. The pt was unharmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 476171 |
| MDR Report Key | 476171 |
| Date Received | 2003-07-28 |
| Date of Report | 2002-11-01 |
| Date of Event | 2002-07-01 |
| Date Added to Maude | 2003-08-08 |
| 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 | 0 |
| 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 | * |
| Generic Name | RADIATION PROTECTION DOOR |
| Product Code | EAK |
| Date Received | 2003-07-28 |
| Model Number | 1924 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 4 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 464997 |
| Manufacturer | NELCO, INC |
| Manufacturer Address | 800 WEST CUMMINGS PARK SUITE 3950 WOBURN MA 01801 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-28 |