Catalog Number 33302 |
Device Problems
Inadequate Instructions for Healthcare Professional (1319); 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 and country labels did not match.Reference number (b)(4) was on the control label and reference number (b)(4) was on the country label.
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Manufacturer Narrative
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The device was not returned for evaluation.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:
¿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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Event Description
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It was reported that the control and country labels did not match.Reference number (b)(4) was on the control label and reference number (b)(4) was on the country label.
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Search Alerts/Recalls
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