MAUDE Adverse Event Report: DJO, LLC CHATTANOOGO; INTELECT LEGEND XT COMBOUS STD

Model Number	2760
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Lead(s), Burn(s) From (3161)
Date of Event	06/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
Per 21cfr part 803, an mdr reportable event.Complaint received that alleges i was being treated at a physical therapy office and had two electrodes put on my left hip area for trochanteric bursitis.After the stimulator machine was on for about one minute, i started getting very excruciating soreness in the treated area.Since it was on for only ten minutes, i did not make a connection with the severe burn that resulted.When my therapist came back in the room, the electrodes were removed and when the therapist went to massage the area, the therapist asked if i knew i had some type of pressure sore and did i have any itching, soreness or awareness of the "lesion" that was noticed.I went to my primary care doctor who referred me to a dermatologist.Today, (b)(6) 2016, the dermatologist said it had not healed at all and did a biopsy.I also had my physical med rehab doctor check it out and as soon as he saw the "lesion/burn/sore", he said i was burned by the electrode.To date, even though i was told it is not infected, i was given an antibiotic ointment to put on once a day.That did not work much at all, just a slight decrease in size of wound.At this point i do not know what to do or which doctor's advice i should listen to.I will most likely get the biopsy results in one week, and i will take it from there.My hip is extremely sore, looks disgusting, and until it is healed, if ever, i cannot have any physical therapy for the original trochanteric bursitis.I do not believe the physical therapist made a report but possibly wrote something in my chart.I am afraid of the wound becoming infected and feel this should be reported in case the equipment malfunctioned or the electrodes were not properly connected." device not returned to manufacturer for evaluation.

• Brand Name: CHATTANOOGO
• Common Device Name: INTELECT LEGEND XT COMBOUS STD
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 5875609
• Report Number: 9616086-2016-00019
• Device Sequence Number: 10830490
• Product Code: IMG
• UDI-Device Identifier: 00888912292740
• UDI-Public: 00888912292740
• Combination Product (Y/N): N
• PMA/510(K) Number: K031077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/15/2016

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
• Operator of Device: Health Professional
• Device Model Number: 2760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2016
• Initial Report FDA Received Date: 08/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention