Model Number P01575-010 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Burn(s) (1757); Erythema (1840); Skin Irritation (2076)
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Event Date 04/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported by the patient that when the last sensor was removed, there was skin irritation described as "redness and 1st degree burns around the outer circle and 2nd degree burns around the inner circle." it was also reported that the patient talked to his cardiologist and they "both knew it was second degree burns." the patient treated the skin with over the counter cortisone cream and the skin is much better now.It was further reported that while answering a seeq customer experience survey the patient reported ¿it fell a few days earlier when it stopped working, i think it was not functioning for a few days." the sensor was not replaced.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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The device was returned and analyzed.Analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Corrected information: sex, date of birth, no eval explain code.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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