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Model Number 125365 |
Device Problem
Human-Device Interface Problem (2949)
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Patient Problems
Rash (2033); Skin Irritation (2076)
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Event Type
Injury
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Event Description
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The pt reported she developed a circumferential red rash under the white tape collar of the device.The rash has persisted for approximately 1 year.Further, the pt reported that when the tape collar is removed from the device, the rash resolves on it's own.No further info was provided.
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Manufacturer Narrative
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Analysis is taken from a trending report of evaluations or adverse events finalized 05/2011.The data presented is from three different product applications.The report states that there are no significant trends.Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Device (s) listed in this report is (are) used for treatment, not diagnosis.Any additional info received regarding this event after filing this report shall be filed on a supplemental mdr.
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Search Alerts/Recalls
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