MAUDE Adverse Event Report: TRAVANTI MEDICAL / TAPEMARK CO. IONTO PATCH STAT; DEVICE, IONTOPHORESIS, OTHER USES

Lot Number	7011-4 S-10
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Pt being treated for left lateral epicondylitis: the path had exposed metal.This caused a burn, slightly smaller than a dime.Upon examination, wound had scabbed over and no signs of infection.Pt reports no pain.Location where event occurred: outpatient treatment facility - physical therapy.

• Brand Name: IONTO PATCH STAT
• Common Device Name: DEVICE, IONTOPHORESIS, OTHER USES
• Manufacturer (Section D): TRAVANTI MEDICAL / TAPEMARK CO.
• MDR Report Key: 8424840
• Report Number: MW5084930
• Device Sequence Number: 16191300
• Product Code: EGJ
• UDI-Device Identifier: 10815611020005
• UDI-Public: 10815611020005
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/08/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Lot Number: 7011-4 S-10
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2019
• 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: Other
• Patient Age: 46 YR