Involved male patients in a nursing home.Using permanent catheterization.It's been few days that nurses noticed for several male patients some small cuts on the top of the penis.It's not linked to the balloon.It's like an irritation.The small cuts lead to small bleeding, the issue is that it is not healing for the moment because it's a permanent catheterization.It could be an issue with the positioning of the catheters but we cannot exclude it is an issue with devices.It happened with 2 references (b)(4), sizes are unknown and lot# are unknown.Catheters are still in situ on patients at the time of logging.It will be asked to nurses to keep them when removed.Additional information: the cuts are on the head of the penis.Bleeding occurred for some patient's and sometimes blood seen in urine after device replacement.The patient's wear full diapers with a net to hold tubing and urine bag and bed bag holder.No medical intervention performed and no treatment with antibiotics.The cuts with bleeding have not stopped.
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(b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed qa inspection test.An actual sample with the urine bag was returned for investigation.It was reported that a male patient using permanent catheterization and had experienced small bleeding due to a small cut.It was likely like an irritation during catheterization period.Visual examination on the returned sample observed that the catheter had slight discolored at some part and encrustation on the catheter.Besides that, no other abnormalities or sharp edge was observed.According to the complaint description, it i believed that the patients are pulling catheters regularly as this kind of issues always happened with patients with long term catheterization.Also, it was stated that the catheter was initially not maintained or secured properly.Review on manufacturing, there is no change of material or processes that might affect the hardness, flexibility and durability of silicone catheter.The catheters are subject to 100% inspection for its functionality prior to product packing and shipment.According to ifu, there is potential complications such as catheter associated urinary tract infections, urgency and tenesmus, irritations of urethral mucosa and blockage of the catheter due to encrustations.Incorrectly positioned catheter can cause urethral damage if the balloon is inflated within urethra.Due to possible diffusion, it is recommended to check the volume of the balloons with sterile water at least once per week.It is recommended as well to visually inspect the catheter for any mechanical damage before use.Based on the complaint reported, such pressure ulcers phenomenon likely could occur due to continues pressure from any source and improper securement of the catheter.Literature also had suggested the importance of medical staff to be aware the need to remove or reposition the device and others as discuss above.Thus, this complaint is not confirmed.
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Involved male patients in a nursing home.Using permanent catheterization.It's been few days that nurses noticed for several male patients some small cuts on the top of the penis.It's not linked to the balloon.It's like an irritation.The small cuts lead to small bleeding, the issue is that it is not healing for the moment because it's a permanent catheterization.It could be an issue with the positioning of the catheters but we cannot exclude it is an issue with devices.It happened with 2 references (170605-xxxx and 174030-xxxx), sizes are unknown and lot# are unknown.Catheters are still in situ on patients at the time of logging.It will be asked to nurses to keep them when removed.Additional information: the cuts are on the head of the penis.Bleeding occurred for some patient's and sometimes blood seen in urine after device replacement.The patient's wear full diapers with a net to hold tubing and urine bag and bed bag holder.No medical intervention performed and no treatment with antibiotics.The cuts with bleeding have not stopped.
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