The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿operator error or utilization of incorrect mixing checklist¿.Which resulted in insufficient mix parameters for silicone (time too high).It was unknown whether the device had met specifications.The product used for the treatment purposes.The device was not returned for evaluation.The lot number was 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.".
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