INTELECT 2738

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-10 for INTELECT 2738 manufactured by Chattanooga Medical Supply, Inc.

Event Text Entries

[14965631] Pt reportedly sustained a burn which blistered on her shoulder after ultrasound machine applied over area as part of pt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5021706
MDR Report Key2211452
Date Received2011-08-10
Date of Report2011-08-03
Date of Event2011-07-20
Date Added to Maude2011-08-18
Event Key0
Report Source CodeVoluntary 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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameINTELECT 2738
Generic NameULTRASOUND MACHINE
Product CodeIMI
Date Received2011-08-10
Model Number2738
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerCHATTANOOGA MEDICAL SUPPLY, INC
Manufacturer Address827 INTERMONT RD CHATTANOOGA TN 37415 US 37415


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-08-10

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