MAUDE Adverse Event Report: DJO LLC VITALSTIM SMALL ELECTRODES; ELECTRODE, CUTANEOUS

Model Number	59005
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient allegedly experienced a reaction (redness on skin) from either the gel on the actual electrode or the adhesive around the electrode.The patient was taken to the hospital and an epipen was administered.Per the ifu for these electrodes, it states "some patients may experience skin irritation or hypersensitivity due to electrical stimulation or electrical conductive medium.The irritation can usually be reduced by moistening the skin, using an alternative conductive medium or electrode placement." it is unknown what caused the patient's reaction to the product.Djo was unable to perform an investigation on the electrodes used on the patient as they were disposed of by the treatment facility.The root cause of the reaction is unknown as it occurred again while a non djo electrode was used on the patient during the emergency room visit.The patient was treated and released to the parents after a few hours of observation.
Event or Problem Description
It was reported that the patient allegedly experienced a reaction (redness on skin) from either the gel on the actual electrode or the adhesive around the electrode.

• Brand Name: VITALSTIM SMALL ELECTRODES
• Common Device Name: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; suite 200; carlsbad CA 92010
• MDR Report Key: 12484941
• Report Number: 9616086-2021-00014
• Device Sequence Number: 5359983
• Product Code: GXY
• UDI-Device Identifier: 00888912357074
• UDI-Public: 00888912357074
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

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: 59005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/16/2021
• 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; Required Intervention