The graft remains implanted.Therefore, a comprehensive records re-review was conducted.There were no departures noted during records re-review that would negatively impact the manufacturing of xenografts from lot pd18100001.Manufacturing records indicated that serial ids (b)(4) (report #3002924436-2020-00001) and (b)(4) met all specifications and release criteria prior to distribution.There is one related complaint for seroma formation for the lot, also associated with the same physician (name not reported at this time).Porcine dermis xenografts undergo a validated sterilization method: tutoplast®, which includes terminal sterilization by gamma irradiation after packaging.To date, our investigation indicates that the reported complications are more likely associated with one or more extrinsic factors, rather than an intrinsic property of the fortiva porcine dermis xenografts.
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Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly owned subsidiary of rti, received a complaint as part of the fortiva appear trial.The reported complaint indicated that a patient underwent bilateral nipple conserving mastectomy.There were drains placed on the right and on the left chest wall.The drains were removed on (b)(6) 2019 due to pain.The patient was discharged with no additional medications on (b)(6) 2019.On (b)(6) 2019 the patient was noticed to have developed a seroma of the right breast and an aspiration was performed (unknown date).The seroma resolved without residual effects.
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