FERNO STAINLESS STEEL PARAFFIN BATH 930

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-04-02 for FERNO STAINLESS STEEL PARAFFIN BATH 930 manufactured by Ferno-washington, Inc..

Event Text Entries

[230365] Customer claims temperature fluctuates high/low wihtout manual adjustment. No report of injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1523574-2002-00035
MDR Report Key386554
Report Source06
Date Received2002-04-02
Date of Report2002-03-11
Date Mfgr Received2002-03-11
Device Manufacturer Date2002-02-01
Date Added to Maude2002-04-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactRICHARD HICOL
Manufacturer Street70 WEIL WAY
Manufacturer CityWILMINGTON OH 45177
Manufacturer CountryUS
Manufacturer Postal45177
Manufacturer Phone*
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFERNO STAINLESS STEEL PARAFFIN BATH
Generic NameTHERAPY
Product CodeIMC
Date Received2002-04-02
Model Number930
Catalog Number930
Lot NumberM-480480
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key375592
ManufacturerFERNO-WASHINGTON, INC.
Manufacturer Address70 WEIL WAY WILMINGTON OH 45177 US
Baseline Brand NameFERNO PARAFFIN BATH
Baseline Generic NamePARAFFIN BATH
Baseline Model No930
Baseline Catalog No930
Baseline Device FamilyFERNO STAINLESS STEEL PARAFFIN BATH
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2002-04-02

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