REMINGTON PARAFIN WAX HEAT TREATMENT SYSTEM HS-225 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-13 for REMINGTON PARAFIN WAX HEAT TREATMENT SYSTEM HS-225 * manufactured by Unk.

Event Text Entries

[234859] Incident description: in the latter part of 1999, reporter purchased a remington parrafin wax heat treatment system model hs-225. Reporter warmed up the wax in the system as instructed in the user's manual. When reporter attempted to use the system by dipping right hand into the wax, the wax burned the reporter. Reporter immediately and violently removed hand from the wax, causing wax to splatter on the floor, table and wall. Reporter experienced a minor burn to hand. The thought that skin might be super-sensitive to the heat, so reporter asked a family member to do the same and the family member too could not bear the heat even long enough to cover whole hand. The same thing happened when reporter tried to dip foot into the wax. Reporter resolved not to use the system and to take it back. But reporter procrastinated and weeks turned into over a year now. Reporter called the co to see if there was anything they could do. Maybe they had figured out that they need a temperature control gauge becasue their product is scalding people. Reporter was told that the product is supposed to heat up to 145 or 148 degrees, so that the wax will melt. This is very hot. Reporter told them that reporter could not bear the heat and they said that others had experienced the same problem but that there was nothing they were willing to do. Although reporter's options are all but exhausted now, remington should not be allowed to make a product that causes such injuries. Even if reporter were to turn off the machine to let the wax cool down even a little. The wax starts to solidify before it reaches a bearable temperature. Date product purchased = december 4, 1999.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1021278
MDR Report Key319702
Date Received2001-02-13
Date of Event1999-12-01
Date Added to Maude2001-03-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameREMINGTON PARAFIN WAX HEAT TREATMENT SYSTEM
Generic Name*
Product CodeIMC
Date Received2001-02-13
Model NumberHS-225
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key309233
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
10 2001-02-13

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