N/A

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number5607590
MDR Report Key5607590
Date Received2016-04-26
Date of Report2015-12-08
Date of Event2015-12-02
Report Date2015-12-08
Date Reported to FDA2015-12-08
Date Reported to Mfgr2015-12-08
Date Added to Maude2016-04-26
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameN/A
Generic NameSHIELD, PROTECTIVE, PERSONNEL
Product CodeKPY
Date Received2016-04-26
Model NumberN/A
Catalog NumberN/A
Lot NumberN/A
ID NumberN/A
Device Availability*
Device Age6 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerEL DORADO METALS
Manufacturer Address122 PELLIZZARI PLACE EL DORADO AR 71730 US 71730


Patients

Patient NumberTreatmentOutcomeDate
10 2016-04-26

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