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Catalog Number DYND23402 |
Device Problem
Material Deformation (2976)
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Patient Problems
Tissue Breakdown (2681); Skin Inflammation/ Irritation (4545)
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Event Date 03/27/2023 |
Event Type
Injury
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Manufacturer Narrative
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According to the customer, the condom catheters will not "completely unroll" causing "a red ring/irritation".The customer reported patients' skin damage are "equivalent to stage 2 wound" requiring "wound care, barrier paste twice daily, and wound care following up on injury".The sample has been requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
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Event Description
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According to the customer, the condom catheters will not "completely unroll" causing "a red ring/irritation".
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Search Alerts/Recalls
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