Model Number 36304 |
Device Problems
Nonstandard Device (1420); Appropriate Term/Code Not Available (3191)
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Patient Problems
Itching Sensation (1943); No Consequences Or Impact To Patient (2199)
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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 allegedly experienced itching with use of device.The adhesive was stronger than usual and caused the patient to leave the mec on for two days.No medical intervention was required.
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Manufacturer Narrative
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The device was not returned for evaluation.A potential failure mode could be ¿too high viscosity¿ with a potential root cause of ¿viscometer failure or mechanical failure¿.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: ¿description/ indication: the self-adhering male external catheter is designed for the management of male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Precaution: do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply: wash penis with mild soap and warm water.Dry thoroughly.Trim pubic hair if necessary.Open package at perforation.To remove plastic insert, squeeze catheter at the top of the white cone and pull to release.Unroll self-adhering catheter over penis.Gently squeeze the catheter to properly seal adhesive to the skin.Connect to collection bag.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.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.".
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Event Description
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It was reported that the patient allegedly experienced itching with use of device.The adhesive was stronger than usual and caused the patient to leave the mec on for two days.No medical intervention was required.
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Search Alerts/Recalls
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