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Model Number 125265 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Wound Dehiscence (1154); Tissue Breakdown (2681)
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Event Date 12/10/2012 |
Event Type
Injury
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Event Description
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End-user reported that the right, middle and left area of abdominal skin presented as an open wound with leakage and peeling skin, located under all of wafer; tape collar extending beyond the appliance.
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Manufacturer Narrative
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Based on the available info, this event is deemed a serious injury.It is reported that the following skin care is performed by end-user: uses alcohol; dove soap; and stomahesive powder.End-user was provided instructions in appropriate and proper skin care.It is reported that end -user will try sur-fit natura moldable convex product with eakin cohesive seals.End-user was encouraged to follow-up with a health care provider if condition persists.Lastly, it is reported that end-user has scheduled a visit to see dermatologist.No additional pt/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow report will be submitted.
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Manufacturer Narrative
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Additional information was received on september 23, 2015.The product associated with lot#3d00375 was manufactured according to specification.After a thorough batch review no discrepancies or non-conformances were discovered.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Previous investigation is applicable to this complaint.Therefore, this complaint will remain open until completion of the investigation.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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Manufacturer Narrative
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The product associated with batch 3d00375 was made according to specification.After detailed batch review, no discrepancies, including non-conformances/deviations, were found.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Previous non-conformance is applicable to this complaint and is closed.No further actions are required, and this complaint will be closed.The complaint/incidence data-post market analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user is a result of skin complications caused by a variety of external factors not related to the design, materials, and/or processes of the product.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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