Model Number SC1200 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Rash (2033); Skin Infection (4544)
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Event Date 02/01/2022 |
Event Type
Injury
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Event Description
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The customer reports a rash with what is described as needle sized blood marks that developed into blisters with puss drainage.The dermatologist was seen and the customer received injection antibiotics as well as a topical cream.The area of infection was opened and cleaned by the md and required 3 stitches.
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Manufacturer Narrative
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File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.Soclean believes this complaint is related to the philips recall of the dreamstation 1, not the soclean device.Soclean is processing this complaint in accordance with its complaint handling and quality system processes.
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Manufacturer Narrative
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File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.Soclean believes this complaint is related to the philips recall of the dreamstation 1, not the soclean device.Soclean is processing this complaint in accordance with its complaint handling and quality system processes.
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Event Description
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The customer reports a rash with what is described as needle sized blood marks that developed into blisters with puss drainage.The dermatologist was seen and the customer received injection antibiotics as well as a topical cream.The area of infection was opened and cleaned by the md and required 3 stitches.
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Search Alerts/Recalls
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