A sample was not returned.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to determine the root cause of the alleged injury or whether an electrode was the root cause.This is an on-going low-level issue which was identified through customer complaints.Multiple studies are regularly conducted that have demonstrated appropriate device biocompatibility and safety performance criteria when the device is used appropriately on humans.Known failure modes include allergies and sensitivities to adhesives or other components and incorrect use of product.
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A 5-week-old male experienced left upper chest erythema, skin tears, maceration, and a 4cm x 4cm blister in less than 24-hours post application of 3m¿ red dot¿ neonatal, pre-wired, radiolucent monitoring electrode with clear tape, 2269t lot: 202407ab.Medical treatment was reportedly required described as wound care that included treatment with 3m¿ cavilon¿ no sting barrier film, and the symptoms subsequently resolved after three days.
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