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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: METTLER ELECTRONICS CORP INTERFERENTIAL SYS*STIM 220; INTERFERENTIAL CURRENT THERAPY
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METTLER ELECTRONICS CORP INTERFERENTIAL SYS*STIM 220; INTERFERENTIAL CURRENT THERAPY Back to Search Results
Model Number 220
Device Problem Temperature Problem (3022)
Patient Problems Unspecified Infection (1930); Partial thickness (Second Degree) Burn (2694)
Event Date 03/23/2016
Event Type  malfunction  
Event Description
Patient set up on ifc (interferential current therapy) without incident.He stated he had no pain and was comfortable.Patient given a call light and encouraged to press call button if needing assistance during the 15 min.Treatment.Approximately 7 minutes into treatment, he felt the electrode was getting hot.No redness or blistering where electrodes had been.Electrodes were repositioned and therapy continued and was completed without obvious signs of injury.Patient sustained burn (2nd degree) to shoulder from an electrode during ifc treatment.He continues to treat the subsequent infection to the site.There was some conjecture that the patient used a topical pain ointment prescribed by md that may have impacted the conductivity of the electrodes.Equipment under analysis by manufacturer.
 
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Type of Device
INTERFERENTIAL CURRENT THERAPY
Manufacturer (Section D)
METTLER ELECTRONICS CORP
1333 s. claudina st.
anaheim CA 92805
MDR Report Key5655572
MDR Text Key45199599
Report Number5655572
Device Sequence Number1
Product Code LIH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/26/2016,04/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number220
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2016
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/26/2016
Device Age19 YR
Event Location Other
Date Report to Manufacturer04/26/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/16/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
OTHER, PT SUSTAINED BURN (2ND DEGREE) TO SHOULDE
Patient Outcome(s) Other;
Patient Age53 YR
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