Model Number 39303 |
Device Problem
Material Integrity Problem (2978)
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Patient Problems
Pain (1994); Excessive Tear Production (2235); Skin Tears (2516)
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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 male external catheter had too much adhesive.The patient allegedly experienced pain and skin tearing.No patient injury or medical intervention reported.
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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: "directions: to remove gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive." the device was not returned.
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Event Description
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It was reported that the male external catheter had too much adhesive.The patient allegedly experienced pain and skin tearing.No patient injury or medical intervention reported.
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Search Alerts/Recalls
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