CONVATEC DOMINICAN REPUBLIC, INC. ACTIVLIFE 1 PC - 1 PC DRAINABLE POUCH W/ DURAHESIVE (DH) PLUS; POUCH, COLOSTOMY
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Model Number 400599 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Itching Sensation (1943); Burning Sensation (2146)
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Event Date 04/05/2012 |
Event Type
Injury
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Event Description
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Report received indicated that the first time the pt applied the 1 piece pouch there was a little itching and burning sensation under the mass only.When the appliance was changed the next day, the pt felt a greater degree of itching and burning and had to remove the new appliance after one day of wear.The skin was splotchy, red, dry and burning, especially at the bottom and both side under the mass only.No further info was provided and the pt outcome was not reported.
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Manufacturer Narrative
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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 add'l info received regarding this event after filing this report shall be filed on a supplemental mdr.A lot number could not be obtained therefore a review of the batch record data could not be performed without a valid lot number.(b)(4).No events or capas relating to the complaint issue were found in the global non-conformance reporting system for the previous 12 months of case creation.It is noted that there are blank areas on this form, the info was not provided or is unk.
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