Model Number 35302 |
Device Problems
Nonstandard Device (1420); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
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Patient Problems
Pain (1994); Skin Irritation (2076)
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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 had difficulty removing the male external catheters due to the adhesive sticking too strongly.The patient was in the shower for about 10 minutes soaking the catheter with warm water and soap, however the adhesive continued to stick and was painful to remove and allegedly irritated his skin.No medical intervention was 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: ¿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 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) unroll self-adhering catheter over penis.4) gently squeeze the catheter to properly seal adhesive to the skin.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.5) connect to drainage device.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." section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that the patient had difficulty removing the male external catheters due to the adhesive sticking too stongly.The patient was in the shower for about 10 minutes soaking the catheter with warm water and soap, however the adhesive continued to stick and was painful to remove and allegedly irritated his skin.No medical intervention was reported.
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Search Alerts/Recalls
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