Received 5 hydrocolloid adhesive sheath lot samples.The reported event was unconfirmed, since the samples met specification.The samples were visually inspected for holes or damage on the package, legibility of printed numbers and letters, expiration date, correct impression, print color, missing parts of printing, position of printing, damaged component, foreign matter.Per functional testing, the samples were evaluated according to the alleged failure mode: "strong adhesive" and were found within specification, acceptable peel strength must be in a range from 0.60 to 2.10 lbf.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "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 wash penis with mild soap and warm water.Dry thoroughly.Trim pubic hair if necessary.Unroll self-adhering catheter over penis.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.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" (b)(4).
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