The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to customer's infusion site infection and er visit.Lot release and sterilization records were reviewed and the product lot met all acceptance criteria.Omnipod insulin management system ¿ user guide.Model: ent450.17845-5c-aw rev a 10/17.Changing your pod 3 / page 24.Warning: to minimize the possibility of site infection, do not apply a pod without first using aseptic technique.This means to wash your hands, clean the insulin vial with an alcohol prep swab, clean the infusion site with soap and water and keep sterile materials away from any possible germs.Changing your pod 3 / page 34.Warning: if an infusion site shows signs of infection; immediately remove the pod and apply a new one at a different site.Contact your healthcare provider.Treat the infection according to instructions from your healthcare provider.Living with diabetes 11 / page 117.At least once a day, use the pod¿s viewing window to inspect the infusion site.Check the site for signs of infection, such as pain, swelling, redness, discharge or heat.
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It was reported that after wearing the pod on the leg between 24 and 36 hours, the site was painful, red and hot to the touch with difficulty to walk.The patient visited the emergency room (er) where he was treated with intravenous (iv) antibiotics for 4 days (name not specified) and given additional 10 days to be taken upon discharge.
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