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U.S. Department of Health and Human Services

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

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BRAEMAR MANUFACTURING, LLC 1-CHANNEL HOLTER MONITOR CARDIOKEY Back to Search Results
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.
 
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Brand Name1-CHANNEL HOLTER MONITOR CARDIOKEY
Type of Device1-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 Key8780756
MDR Text Key150713014
Report Number2133409-2019-00008
Device Sequence Number1
Product Code MWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130294
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number100-0030-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2019
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?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/11/2019 Patient Sequence Number: 1
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