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 |