MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-26 for N/A manufactured by El Dorado Metals.
[43632833]
Patient Sequence No: 1, Text Type: N, H10
[43632834]
Reportedly, the lead door to a radiation oncology treatment room was unable to be closed. The room was closed for approximately 90 minutes and was re-opened following service by the manufacturer. Reportedly, no harm to patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5607590 |
| MDR Report Key | 5607590 |
| Date Received | 2016-04-26 |
| Date of Report | 2015-12-08 |
| Date of Event | 2015-12-02 |
| Report Date | 2015-12-08 |
| Date Reported to FDA | 2015-12-08 |
| Date Reported to Mfgr | 2015-12-08 |
| Date Added to Maude | 2016-04-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | SHIELD, PROTECTIVE, PERSONNEL |
| Product Code | KPY |
| Date Received | 2016-04-26 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | N/A |
| Device Availability | * |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EL DORADO METALS |
| Manufacturer Address | 122 PELLIZZARI PLACE EL DORADO AR 71730 US 71730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-26 |