According to the complainant the device will not be available for investigation because it was discarded by the patient.We are unable to determine if any product condition could have contributed to the adhesive allergic reaction.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 intracutaneous 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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It was reported the patient developed an allergic reaction to the pod adhesive while worn on the abdomen for between 5 and 24 hours.When the pod was removed, the patient noted blisters, chemical burns and skin peeling off where the pod was applied.No medical intervention was sought and the pod was discarded by the patient.
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