*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-30 for * manufactured by Ohmeda Medical.

MAUDE Entry Details

Report Number4973094
MDR Report Key4973094
Date Received2015-06-30
Date of Report2015-06-30
Date of Event2015-05-05
Report Date2015-06-30
Date Reported to FDA2015-06-30
Date Reported to Mfgr2015-08-05
Date Added to Maude2015-08-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameTRANSILLUMINATOR, AC-POWERED
Product CodeHJM
Date Received2015-06-30
Model Number*
Catalog Number*
Lot NumberGDPUM0202
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerOHMEDA MEDICAL
Manufacturer Address8880 GORMAN RD. LAUREL MD 20723 US 20723


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-30

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