OMNIBATCH 10 BW *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-09 for OMNIBATCH 10 BW * manufactured by X-rite.

Event Text Entries

[20194225] Exposed to chemical fumes emitted from equipment that malfunctioned in a darkroom in the radiology dept. Symptoms included headache. Equipment removed from hosp, odor dissipated. Sulfur gas emitted. Air test for h2s, results negative. Employee became a pt seen in e. R. Treated & released.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number304192
MDR Report Key304192
Date Received2000-11-09
Date of Report2000-11-08
Date of Event2000-10-30
Date Facility Aware2000-10-30
Report Date2000-11-08
Date Reported to FDA2000-11-08
Date Reported to Mfgr2000-11-08
Date Added to Maude2000-11-15
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameOMNIBATCH 10 BW
Generic NameSAFETY KLEEN SILVER RECOVERY UNIT
Product CodeIXW
Date Received2000-11-09
Returned To Mfg2000-10-30
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key294376
ManufacturerX-RITE
Manufacturer Address44TH ST SW GRANDVILLE MI 494182357 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2000-11-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.