Model Number 35304 |
Device Problems
Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
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Patient Problem
Urinary Tract Infection (2120)
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Event Type
Injury
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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 catheters were not unrolling all the way, and urine was collecting in the tip and not draining properly.The patient alleged that the issue caused uti's (urinary tract infections).The patient was not treated by a doctor for a urinary tract infection.
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Manufacturer Narrative
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The device was not returned for evaluation.A potential failure mode could be ¿barcode malfunction¿ with a potential root cause of ¿plc failure or damaged barcode¿.This failure falls in a quad 1 risk region and based on this information the risk is low.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." h11: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.H3 other text : the device was not returned.
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Event Description
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It was reported that the male external catheters were not unrolling all the way, and urine was collecting in the tip and not draining properly.The patient alleged that the issue caused uti's (urinary tract infections).The patient was not treated by a doctor for a urinary tract infection.
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Search Alerts/Recalls
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