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Model Number 421739 |
Device Problem
Sharp Edges (4013)
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Patient Problem
Discomfort (2330)
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Event Type
malfunction
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Manufacturer Narrative
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Device 5 of 6.Age at the time of event - 93 years.The consumer transitioned from ref 413335.However, it is an unknown model number of to be determined aps pouches, assumed to be 421739.Based on the available information, this event is deemed to be a reportable malfunction.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092; manufacturing site: 9618003.
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Event Description
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The consumer is a ninety-three-year-old female with an ileostomy since 1972.She threw her boxes away, therefore, no lot number was available.The consumer reported that the belt tabs on approximately six pouches with unknown lot and reference number, felt sharp to her and were digged into her skin which caused sensation.However, no physical harm was noted.Further, she stated that she immediately removed the pouch and applied a new one.She denied skin breakdown or any form on trauma to the skin from the belt tabs and did not wear a belt.The products were not returned.No photo was available at this time.
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Search Alerts/Recalls
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