MAGNATHERM (HEAT THROUGH) UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-14 for MAGNATHERM (HEAT THROUGH) UNK * manufactured by International Medical Electronics, Ltd..

Event Text Entries

[201474] Received modality-magnatherm short wave diathermy using coil plates with each plate placed over buttock area. Settings were 4-8 for 15-20 mins laying on right side position. Received treatment modality - magnatherm short wave diathermy. Treatment prescribed by primary physician for a diagnosis of intervertebral herniation at l-1. Prior symptoms to treatment included radiating pain across right leg down back of right leg. Primary physician prescribed medications consisting of methocarbazepin, 750 mg, cefadroxil 500 mg, prozac 20 mg and codeine 300 mg. Following modality pt experiened excruciating burning (internal) from waist down to under bottom of feet. Contacted physical therapy dept who administered treatment, the complications of treatment. Physical therapy referred pt back to primary physician for complications. Primary physician was unable to see pt until two weeks later. Examination consisted of visual observation and of buttock area and spine and then indicated pt would be alright. After enduring continued pain, burning sensations, drawing, tightness of muscles from waist down to underside of feet on the back side of body, pt finally sought the help of a neurologist whose diagnosis has included, loss of sensations to most body, damaged nerves. Currently, receiving some medication (tegretol 900 mg daily) to help with the pain and discomfort. Currently awaiting appointment for a more definitive diagnosis. Medical records are available upon request. Was not attached at this time due to voluminous nature of records.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1020408
MDR Report Key304966
Date Received2000-11-14
Date of Report2000-11-04
Date of Event1998-09-04
Date Added to Maude2000-11-20
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 NameMAGNATHERM (HEAT THROUGH)
Generic NameSHORT WAVE DIATHERMY (MOBILE)
Product CodeIMJ
Date Received2000-11-14
Model NumberUNK
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key295135
ManufacturerINTERNATIONAL MEDICAL ELECTRONICS, LTD.
Manufacturer Address3939 BROADWAY KANSAS CITY MO 64111 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2000-11-14

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