This mdr is being submitted due to the reported seroma and fever after initial placement of the acell device.The device was not explanted and is performing as expected.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with acell's operating procedures and federal, state, and local laws and regulations.
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On (b)(6) 2020, acell, inc.Was notified that a patient experienced a fever and seroma post implantation of two gentrix devices.The gentrix devices were implanted on (b)(6) 2020 for a c-section.The devices were placed in the uterus incision within the muscle and fascia.The devices were cut down to a smaller size to accommodate the smaller incision and then tacked in place in 4 corners.On (b)(6) 2020, the patient stated having a fever and went to the er.The patient was admitted, and was showing fluid in two spaces from the cat scan.The patient was placed on antibiotics during this visit and was discharged a day later.The patient made an additional visit to the er on (b)(6) 2020 for a fever and abdominal pain.The patient was given antibiotics during this visit and discharged a day later.There was no surgical intervention to resolve the seroma for both visits to the er on (b)(6) 2020 and (b)(6) 2020.The gentrix devices remains in place and are functioning as intended.
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