It was reported that the patient had experienced an open bleeding sore down the side of penis, and that was infected.Patient had been wearing diaper.It was noted that the patient had been using products for more than 90 days.Per additional information received on 05jan2022, it was reported that the patient had experienced an open bleeding sore down the side of the penis.Stated that the patient saw a doctor and a prescription was given.
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The reported event was inconclusive as the reported event could not be replicated during sample evaluation.Visual evaluation noted 2 male external catheters received in closed original packaging with no defects present.However, unable to replicate the reported event therefore it is unknown if the product meet specifications.Although an exact root cause could not be determined a potential root cause could be materials not biocompatible.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "intended use: the self-adhering male external catheter is used for the drainage of urine.The catheter is applied by the patient or caregiver.Description / indication: the self-adhering male external catheter is designed for the management of adult male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury or illness of the patient.Precaution: do not use if allergic reaction occurs or if patient has known allergies to device components.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Follow directions to remove if experiencing swelling, numbness, discomfort, pain, discoloration, or abnormal appearance.Note: if experiencing problems with use of the device, please consult your healthcare professional for assistance.Directions to apply: 1) verify correct size prior to use.2) trim pubic hair if necessary.3) wash penis with mild soap and warm water.Dry thoroughly.Wear time may be reduced if skin is not dry or cream/oil is used.4) open package at perforation.Remove catheter from plastic insert, if present.5) place rolled end over the end of the penis, leaving a small space between the end of the penis and the cone of the catheter.6) unroll the catheter over penis.7) gently squeeze the catheter to properly seal adhesive to the skin.If possible, avoid leaving a rolled ¿collar¿ around the base of the penis.Important: wear time may be reduced if adhesive is not properly sealed to the skin.8) connect the catheter to a drainage system.Make sure to check that connections are secure before use.Directions to remove: 1) ensure drainage bag is empty.2) disconnect catheter from the drainage system.3) gently roll the catheter forward and off the penis.If necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive." corrections: d, f, g, h.H11: section a through f - the information provided by bd represents all 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 actual/suspected device was inspected.
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It was reported that the patient had experienced an open bleeding sore down the side of penis, and that was infected.Patient had been wearing diaper.It was noted that the patient had been using products for more than 90 days.Per additional information received on 05jan2022, it was reported that the patient had experienced an open bleeding sore down the side of the penis.Stated that the patient saw a doctor and a prescription was given.Per customer via phone on (b)(6) 2022, customer stated that customer returned the sample and the sore was at the tip of the penis and customer was prescribed an antibiotic cream by the doctor to treat the sore.Customer would call liberator for obtaining a different size.
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