Catalog Number 2283 |
Device Problems
Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)
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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 patient was unable to use the box of sheaths because the adhesive was really sticky and messy.The ibc asked how the patient was storing them and he said he stored them in a cool dry place.
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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: ¿the sheath is a strapless penile sheath; it has an adhesive coating inside to ensure a safe and simple procedure for fitting.".
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Event Description
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It was reported that the patient was unable to use the box of sheaths because the adhesive was really sticky and messy.The ibc asked how the patient was storing them and he said he stored them in a cool dry place.
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Search Alerts/Recalls
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