Model Number 35101 |
Device Problems
Nonstandard Device (1420); Difficult to Remove (1528)
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Patient Problems
Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
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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 he patient was having a difficult time removing the male external catheter.The patient reported that some skin became raw with sores due to how difficult it was to remove.Warm cloths, baths, and even adhesive removers were used, however there was residue left behind that was difficult to remove.
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Manufacturer Narrative
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The device was not returned for evaluation.The reported event could not be confirmed.A potential root cause for this failure could be "operator error".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.".
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Event Description
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It was reported that he patient was having a difficult time removing the male external catheter.The patient reported that some skin became raw with sores due to how difficult it was to remove.Warm cloths, baths, and even adhesive removers were used, however there was residue left behind that was difficult to remove.
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Search Alerts/Recalls
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