PARACARE 2050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2009-03-06 for PARACARE 2050 manufactured by Chattanooga Group.

Event Text Entries

[1081378] Patients complain of burning sensation when extremities are placed in the paraffin bath containing a different brand of wax. The customer felt that the new wax lacks oil. The customer expressed that the lack of the oil is the source of the burning sensation.
Patient Sequence No: 1, Text Type: D, B5


[8220572] The customer did not return the device for evaluation. Since the device was not returned for evaluation, no root cause can be determined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1022819-2009-00068
MDR Report Key1337143
Report Source01,08
Date Received2009-03-06
Date of Report2009-02-10
Date Mfgr Received2009-02-10
Date Added to Maude2009-03-12
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 FDA0
Event Location0
Manufacturer ContactMR. MICHAEL TREAS
Manufacturer Street4717 ADAMS ROAD
Manufacturer CityHIXSON TN 37343
Manufacturer CountryUS
Manufacturer Postal37343
Manufacturer Phone4238702281
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePARACARE
Product CodeIMC
Date Received2009-03-06
Model Number2050
Catalog Number2050
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCHATTANOOGA GROUP
Manufacturer AddressHIXSON TN US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2009-03-06

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