MIST THERAPY SYSTEM CP-80004 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-06-16 for MIST THERAPY SYSTEM CP-80004 * manufactured by Celleration, Inc..

Event Text Entries

[20768133] Employee at hospital had experienced an incident wher her fingertip touched the tip of the transducer. The incident was reported during a site visit on 4/24/2006 to our sales representative. The employee was trying to adjust the applicator while the system was turned on, which is contrary to the instructions for use. The employee experienced a burn on their finger that was no longer visible at the time of the report. Employee acknowledged that she should have paused the system prior to trying to re-seat the applicator.
Patient Sequence No: 1, Text Type: D, B5


[20826348] Delay in filing this report due to it being the first filed by the manufacturer in device history.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004580659-2006-00002
MDR Report Key726835
Report Source05
Date Received2006-06-16
Date of Report2006-06-12
Date of Event2006-04-24
Date Mfgr Received2006-04-24
Device Manufacturer Date2005-12-01
Date Added to Maude2006-06-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactKATHY SIMPSON, QUALITY CONSULTA
Manufacturer Street10250 VALLEY VIEW RD STE 137
Manufacturer CityEDEN PRAIRIE MN 55344
Manufacturer CountryUS
Manufacturer Postal55344
Manufacturer Phone9522248700
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIST THERAPY SYSTEM
Generic Name*
Product CodeNRB
Date Received2006-06-16
Returned To Mfg2006-05-02
Model NumberCP-80004
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key715249
ManufacturerCELLERATION, INC.
Manufacturer Address* EDEN PRAIRIE MN * US
Baseline Brand NameMIST THERAPY SYSTEM
Baseline Generic Name*
Baseline Model NoCP-80004
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-06-16

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