PSA INFANTCARE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-24 for PSA INFANTCARE * manufactured by Pediatric Services Of America, Inc..

Event Text Entries

[297691] Reporter has family member who used psa moisturizer inhaler (issued in (2003). Four days later device backflowed and water entered pt's lungs. Pt was taken to emergency room of hospital. "had referred device. " an adjustment was needed to the respirator. Pt is doing fine, no need for respirator.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4003637
MDR Report Key500924
Date Received2003-11-24
Date of Report2003-09-29
Date of Event2003-09-29
Date Added to Maude2003-12-16
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePSA INFANTCARE
Generic NameMOISTURIZER INHALER
Product CodeKCO
Date Received2003-11-24
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key489694
ManufacturerPEDIATRIC SERVICES OF AMERICA, INC.
Manufacturer Address2751 CURTISS STREET DOWNERS GROVE IL 605154002 US


Patients

Patient NumberTreatmentOutcomeDate
10 2003-11-24

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