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Model Number 416975 |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problems
Skin Discoloration (2074); Discharge (2225); Skin Inflammation (2443)
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Event Type
Injury
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Manufacturer Narrative
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Based on the available information, this event is deemed to be a serious injury.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.
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Event Description
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The end user reported her peristomal skin is blistered with "areas of open, weepy and discolored skin the size of a volleyball." according to the end user, it was an issue with decreased wear time that resulted in the skin issue.She also stated that she ran out of her appliance and she then "placed nothing over her skin for 2 days and the liquid stool was pooling on her skin and caused the skin to worsen." she saw an emergency room physician who made an unknown diagnosis and prescribed an antibiotic (not otherwise specified).No lab testing was done.End user instructed in proper care of peristomal skin.
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Manufacturer Narrative
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The post market trend analysis, subject matter expert (sme) review, clinical review, and marketing review indicate that a perception in specific markets has caused a consistent rate of complaints by the end user because there is no wear time requirement for the ostomy skin barrier.No further actions are required, and this complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
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Search Alerts/Recalls
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