Model Number 39104 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Itching Sensation (1943); Skin Discoloration (2074)
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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 information provided by bard 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 bard.The device was not returned.
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Event Description
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It was reported that the skin of the patient was red and itchy after removing the male external catheter.The patient visited his doctor and was prescribed a topical ointment.
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Event Description
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It was reported that the skin of the patient was red and itchy after removing the male external catheter.The patient visited his doctor and was prescribed a topical ointment.
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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 states the following: ¿ultraflex self adhering male external catheter spirit style 1 adhesive sheath 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.¿.
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Search Alerts/Recalls
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