MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC 1-CHANNEL HOLTER MONITOR CARDIOKEY

Model Number 100-0030-01

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

Per investigation of events, the patient first started using the device on (b)(6) 2019, after receiving it from the clinic.The patient/caregiver indicated that the electrodes (vermed a10091-5) were changed every two days after showering and letting the skin air dry.Hibiclens wipes were used to clean the skin.Skin irritation and reddening developed, with gradual worsening over the course of six days (no skin breakage).On (b)(6) 2019, the patient/caregiver went to the clinic for observation/counseling and asked for another type of electrode to wear.The clinic provider square cloth electrodes (vermed vmh361 rev.B) that had been provided by distributor (cardionet), due to skin irritation.The skin irritation worsened, with skin breakage, oozing, redness and pain.The cloth electrodes were changed every day after showering, as they would not stay on in the shower.The patient's caregiver did not treat the broken skin, except keeping it clean and dry.It was reported that ointments appeared to irritate the skin.The skin appears to be healing.The affected device has not been returned to the manufacturer for evaluation.No additional information is known to braemar manufacturing, llc at this time.

Event Description

On (b)(6) 2019, the (b)(6) account executive received a communication from an account regarding pediatric patient skin irritation when using cardiokey device.The patient was switched to cloth electrodes as an alternative.The patient's caregiver wanted to obtain more information about what components of the electrode could cause the skin irritation, as the patient will need to wear monitors in the future.After eight days wearing the system, the patient's caregiver reported skin oozing, redness, itchiness, and pain.Note: manufacturer become aware date is 06/14/2019, based on receipt of additional information from patient/caregiver by braemar manufacturing, llc and clinical affairs review and reportability determination, due to pediatric patient state.

• Brand Name: 1-CHANNEL HOLTER MONITOR CARDIOKEY
• Type of Device: 1-CHANNEL HOLTER MONITOR CARDIOKEY
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 8780756
• MDR Text Key: 150713014
• Report Number: 2133409-2019-00008
• Device Sequence Number: 1
• Product Code: MWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2019

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: Lay User/Patient
• Device Model Number: 100-0030-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 YR