Catalog Number 33302 |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Irritation (1941); Skin Discoloration (2074); Skin Irritation (2076)
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Event Type
Injury
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
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Event Description
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It was reported that the male external catheter caused skin irritation.The patient was prescribed mupirocin ointment to be applied to the affected area.
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Manufacturer Narrative
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The device was not returned for evaluation.A potential root cause for this failure could be "materials not biocompatible".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿note: do not use on irritated or compromised skin.Do not use if allergic reaction occurs.Not made with natural rubber latex." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device was not returned.
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Event Description
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It was reported that the male external catheter caused skin irritation.The patient was prescribed mupirocin ointment to be applied to the affected area.
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Search Alerts/Recalls
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