MAUDE Adverse Event Report: METTLER ELECTRONICS, CORP. INTERFERENTIAL SYS STIM 220; INTERFERENTIAL CURRENT THERAPY

Model Number INTERFERENTIAL 220 STIMULATOR

Device Problem Unintended Power Up (1162)

Patient Problem Burn(s) (1757)

Event Date 03/23/2015

Event Type  malfunction  

Event Description

During rehab, the patient had ifc unit on left ankle.In the middle of the treatment the unit increased in power then turned off.Patient did not complain of pain, no redness apparent immediately following the event.Patient saw md 10 days later; noted a small red "burn" on ankle.

• Brand Name: INTERFERENTIAL SYS STIM 220
• Type of Device: INTERFERENTIAL CURRENT THERAPY
• Manufacturer (Section D): METTLER ELECTRONICS, CORP.; 1333 south claudina st.; anaheim CA 92805
• MDR Report Key: 5155483
• MDR Text Key: 28452143
• Report Number: 5155483
• Device Sequence Number: 1
• Product Code: LIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/18/2015,09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: INTERFERENTIAL 220 STIMULATOR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2015
• Event Location: Other
• Date Report to Manufacturer: 08/18/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR