Catalog Number 33303 |
Device Problems
Shipping Damage or Problem (1570); Device Markings/Labelling Problem (2911)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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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.The device was not returned.
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Event Description
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It was reported that the control label and country label of the male external catheter did not match.The control label, and the product within the case, were labeled for reference number (b)(4).However, the country label was labeled for reference number (b)(4).
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Event Description
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It was reported that the control label and country label of the male external catheter did not match.The control label, and the product within the case, were labeled for reference number (b)(4).However, the country label was labeled for reference number (b)(4).
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Manufacturer Narrative
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The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.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.If sheath has an insert, remove it.Not made with natural rubber latex.".
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Search Alerts/Recalls
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