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Model Number 39302 |
Device Problems
Nonstandard Device (1420); Difficult to Remove (1528)
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Patient Problem
Pain (1994)
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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 while trying to remove the external, the adhesive on the catheter was too strong, causing the patient pain.No medical intervention was reported.
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Manufacturer Narrative
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The device was not returned for evaluation.A potential root cause for this failure could be "electrical 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: 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) open package at perforation.4) to remove plastic insert, squeeze catheter at the top of the white cone and pull to release.5) unroll self-adhering catheter over penis.6) gently squeeze the catheter to properly seal adhesive to the skin.7) 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." 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 while trying to remove the external, the adhesive on the catheter was too strong, causing the patient pain.No medical intervention was reported.
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Search Alerts/Recalls
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