ALPINE AIR AIR PURIFIER AND OZONE GEN UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-07-10 for ALPINE AIR AIR PURIFIER AND OZONE GEN UNK manufactured by Alpine Air.

Event Text Entries

[187239] Rptr had unit placed in their place of employment for their medical condition and instead it exacerbated their symptoms which were treated by doubling medication.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1019259
MDR Report Key285075
Date Received2000-07-10
Date of Report2000-07-10
Date of Event2000-02-01
Date Added to Maude2000-07-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameALPINE AIR AIR PURIFIER AND OZONE GEN
Generic NameAIR PURIFIER AND OZONE GENERATOR
Product CodeFRF
Date Received2000-07-10
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorLAY USER/PATIENT
Device Availability*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key275877
ManufacturerALPINE AIR
Manufacturer Address* RAPID CITY SD * US


Patients

Patient NumberTreatmentOutcomeDate
10 2000-07-10

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