It was reported that after wearing the pod on the leg between 37 and 48 hours, the site was sore, red, swollen with a painful and infected lump.The patient visited the doctor's office, who prescribed antibiotics (amoxicillin 500mg tablets) to be taken 3 times a day for 7 days.The pod was discarded.
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According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to customer's infusion site infection.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod is iso10993 compliant, undergoing cytotoxicity, sensitization, genotoxicity, hemolysis, irritation or intracutaneously reactivity, systemic toxicity, and implantation effects testing.The omnipod is sterilized with 100% ethylene oxide gas with a sterility assurance level of 10-6 per iso11135 and eo residual levels in compliance with iso10993.Each lot is confirmed to meet requirements for non-pyrogenicity per iso10993 and sterility per iso11135 prior to release.
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