MAUDE Adverse Event Report: METTLER ELECTRONICS CORP. AUTO*THERM SHORTWAVE DIATHERMY; ME 300

Model Number ME 300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 04/01/2015

Event Type  Injury  

Manufacturer Narrative

The autotherm 300, model me300, shortwave diathermy is a pre-amendment (<1976) device that is no longer being produced.

Event Description

On (b)(6) 2015, (b)(6) (marketing manager) received a phone call from dr.(b)(6) (chiropractor in (b)(6)).He stated that in april he treated a patient on the back of the calf to relieve muscle cramping in the calf.Patient had jeans on during the treatment.He reported burning feeling during the treatment.The doctor rubbed on the area to dissipate sweat in the area and resumed the treatment.No additional discomfort was reported by the patient.The patient has diabetes and is a male, approximately (b)(6).He exercises regularly and is in generally good health, all according to the doctor.After returning home to (b)(6), the patient called and reported a penny size burn on the back of the calf.He had sought medical attention and has had intervention by a wound care specialist.The wound is now a dime size and is still not completely healed, as noted by the doctor during phone conversation.Dr.(b)(6) stated that he always treats patients over their clothing and has never had a problem.He does take care to make sure there is no metal in the treatment area.An le (manufacturer's quality systems associate) called dr.(b)(6) back on (b)(6) 2015 to get more information.He refused to send the device back to manufacturer's facility for evaluation.He also mentioned that he already tested the device on himself and no problem was found.So he decided to continue using the device for other patients and no complaint was made so far.

• Type of Device: ME 300
• Manufacturer (Section D): METTLER ELECTRONICS CORP.; 1333 south claudina st.; anaheim CA 92805
• Manufacturer Contact: rob fleming ; 1333 south claudina st.; anaheim, CA 92805 ; 7145332221
• MDR Report Key: 4977081
• MDR Text Key: 22389379
• Report Number: 2013558-2015-00001
• Device Sequence Number: 1
• Product Code: IMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Not Applicable
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ME 300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention