Model Number UNKNOWN |
Device Problems
Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
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Patient Problems
Erythema (1840); Headache (1880); Itching Sensation (1943); Sneezing (2251); Unspecified Respiratory Problem (4464); Blister (4537); Skin Inflammation/ Irritation (4545)
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Event Date 07/31/2022 |
Event Type
Injury
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Manufacturer Narrative
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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).
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Event Description
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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).
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Manufacturer Narrative
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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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Search Alerts/Recalls
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