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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC MOBILE CARDIAC OUTPATIENT TELEMETRY DEVICE; DETECTOR AND ALARM, ARRHYTHMIA
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BRAEMAR MANUFACTURING, LLC MOBILE CARDIAC OUTPATIENT TELEMETRY DEVICE; DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number UNKNOWN
Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problems Erythema (1840); Headache (1880); Itching Sensation (1943); Sneezing (2251); Unspecified Respiratory Problem (4464); Blister (4537); Skin Inflammation/ Irritation (4545)
Event Date 07/31/2022
Event Type  Injury  
Manufacturer Narrative
The following is taken from medwatch mw5111304: i had a inflamed/burning/blistering skin reaction to prescribed electrode patches used with an mcot (mobile cardiac outpatient telemetry) cardiac telemetry device.The patch was labeled lot u600401, ref 02-01609 exp 2023-09.Day 1: skin prepared as instructed.Day 2: itching developed.Day 3: patch changed/skin prepared as instructed.Day 4: itching developed.Day 6: itching developed.Patches changed/skin prepared as instructed.Day 6: itching/red inflamed bumps developed.Day 7: patch removed.Skin red/inflamed and itchy.Red bumps/patches where electrode was developed and some bumps began blistering.Sneezing, sinus inflammation and slight headache began.Patch was removed permanently.Skin washed with water to remove patch adhesive/gel.Day 7: began treatment with clobetasol propionate ointment.05% on non-blistering spots to reduce inflammation.Fda safety report id# (b)(4).
 
Event Description
The following is taken from medwatch mw5111304: i had a inflamed/burning/blistering skin reaction to prescribed electrode patches used with an mcot (mobile cardiac outpatient telemetry) cardiac telemetry device.The patch was labeled lot u600401, ref 02-01609 exp 2023-09.Day 1: skin prepared as instructed.Day 2: itching developed.Day 3: patch changed/skin prepared as instructed.Day 4: itching developed.Day 6: itching developed.Patches changed/skin prepared as instructed.Day 6: itching/red inflamed bumps developed.Day 7: patch removed.Skin red/inflamed and itchy.Red bumps/patches where electrode was developed and some bumps began blistering.Sneezing, sinus inflammation and slight headache began.Patch was removed permanently.Skin washed with water to remove patch adhesive/gel.Day 7: began treatment with clobetasol propionate ointment.05% on non-blistering spots to reduce inflammation.Fda safety report id# (b)(4).
 
Manufacturer Narrative
Patient enrollment verified.Patient was using the universal patch 02-01609 which was the cause of the skin irritation.Patch is a disposable item and was not able to be retrieved.Marsi, skin burn, and associated symptoms may inherently occur under the course of ecg monitoring.No single factor or combination of factors can be attributable to electrode skin irritation and associated symptoms.The product labeling advises patients of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.
 
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Brand Name
MOBILE CARDIAC OUTPATIENT TELEMETRY DEVICE
Type of Device
DETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
BRAEMAR MANUFACTURING, LLC
1285 corporate center drive
suite 150
eagan MN 55121
Manufacturer (Section G)
BRAEMAR MANUFACTURING, LLC
1285 corporate center dr
suite 150
eagan MN 56121
Manufacturer Contact
beverly okoh
1285 corporate center drive
suite 150
eagan, MN 55121
6124263781
MDR Report Key15307707
MDR Text Key298774297
Report Number2133409-2022-00005
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153473
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUNKNOWN
Device Lot NumberU600401
Was Device Available for Evaluation? No
Date Manufacturer Received08/23/2022
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 Number1
Patient Outcome(s) Other;
Patient Age54 YR
Patient SexFemale
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