PERFORMA VE ELECTRODE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-09 for PERFORMA VE ELECTRODE * manufactured by Patterson Medical.

Event Text Entries

[444511] Patient was being treated for scarring on the right dorsal wrist with iontophoresis with saline. The arm was prepped for treatment according to protocol. The patient washed and dried arm. The therapist cleaned the treatment sites with alcohol wipes and allowed it to dry. The electrodes were applied securely and in addition were secured with a wrap for better contact. The unit wires were secured to the electrode pads and the unit settings were adjusted to protocol levels. When the power was turned on and the intensity ramped to treatment level (3. 9) the patient complained of discomfort that was resolved with the application of more wrap for better skin contact of the electrodes. The patient had had several other treatments without incident and was familiar with how the treatment should feel (often with mild discomfort). The patient's discomfort decreased with the application of the wrap and the patient completed the 10 minute treatment with the same level of minor discomfort as experienced with previous treatments. When the treatment was finished and the electrodes removed the patient had a 3 mm circle burn on the outside corner of the inactive electrode on the proximal medial forearm. It was washed with sterile saline and dressed with a sterile dressing. The patient saw a primary care physician the next day and was treated with silvadine and dressing. The patient was seen by occupational therapy today and the burn was healing with no evidence of infection.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 668097
• MDR Report Key: 668097
• Date Received: 2005-12-09
• Date of Report: 2005-12-09
• Date of Event: 2005-11-03
• Report Date: 2005-12-09
• Date Reported to FDA: 2005-12-09
• Date Added to Maude: 2006-01-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PERFORMA VE ELECTRODE
• Generic Name: ELECTRODE
• Product Code: KTB
• Date Received: 2005-12-09
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: N
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 657465
• Manufacturer: PATTERSON MEDICAL
• Manufacturer Address: 270 REMINGTON BLVD., SUITE C BOLINGBROOK IL 604403593 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-12-09