FDA.reportPublic FDA data

MAUDE MDR 28154

MDR report key
28154
Report number
MW1007707
Event key
0
Event type
3
Date of event
1995-10-18
Date received
1995-11-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDI-AIRE BIOLOGICAL ODOR ELIMINATOR, 1 OZODOR ELIMINATORC.R. BARD, INC.FRF7000 LNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11995-11-1701. O

Event Narratives#

D

Patient 1

40-YR-OLD FEMALE DEVELOPED RESPIRATORY DISTRESS FROM BIOLOGICAL ODOR SPRAY. SHE WENT INTO RESPIRATORY DISTRESS WITH SYNCOPAL EPISODE AFTER ANOTHER EMPLOYEE HAD SPRAYED THE ODOR ELIMINATOR TO ELIMINATE ODOR ON INTENSIVE CARE UNIT. REQUIRED SOLUMEDROL 100%, NON-REBREATHER MASK WITH O2 AT 15 LPM AND NEBULIZER TREATMENT. WAS ABLE TO GO HOME THAT EVENING APPROX 2 HRS AFTER EVENT.