The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to the skin irritation 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 23-24: warning: do not use a pod if you are sensitive to or have allergies to acrylic adhesives, or have fragile or easily damaged skin.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 or an alcohol prep swab, and keep sterile materials away from any possible germs.Living with diabetes 11 / page 117: infusion site checks: 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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