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

Model Number 59005

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Local Reaction (2035)

Event Date 08/09/2021

Event Type  Injury  

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 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
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; suite 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; carlsbad; vista, CA 92010 ; 5128346301
• MDR Report Key: 12484941
• MDR Text Key: 271855998
• Report Number: 9616086-2021-00014
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 00888912357074
• UDI-Public: 00888912357074
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 59005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention