HOMEDICS PAR250 UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-02-27 for HOMEDICS PAR250 UNK manufactured by Kwonnie Electrical Products, Ltd..

Event Text Entries

[19492168] No user injuries. Thermal protection circuit failed and the unit "overheated to the point of nearly melting the base. "
Patient Sequence No: 1, Text Type: D, B5


[19745353] Response to fda 483 for homedics insepction 12/2006.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1832894-2006-00035
MDR Report Key890637
Report Source04
Date Received2007-02-27
Date of Report2006-12-29
Date of Event2001-10-26
Date Facility Aware2001-10-26
Date Added to Maude2007-08-08
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 Location3
Manufacturer ContactDAVE VANDERLIN
Manufacturer Street3000 PONTIAC TRAIL
Manufacturer CityCOMMERCE TWP. MI 48390
Manufacturer CountryUS
Manufacturer Postal48390
Manufacturer Phone2488633000
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHOMEDICS
Generic NamePARAFIN BATH
Product CodeIMC
Date Received2007-02-27
Model NumberPAR250
Catalog NumberUNK
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Age1 YR
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key867871
ManufacturerKWONNIE ELECTRICAL PRODUCTS, LTD.
Manufacturer Address* KOWLOON HK


Patients

Patient NumberTreatmentOutcomeDate
10 2007-02-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.