This mdr is being submitted due to the reported seroma formation 6 to 8 weeks after initial placement of the acell device.The device was not explanted and is not available for evaluation.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 fda, state, local, and acell's operating procedures.There were no reports of device failure at the time of initial surgery.
|
On (b)(6) 2018 acell received notification from physician regarding a patient who experienced post operative fluid drainage after treatment with an acell device.Patient had repair of a large and symptomatic incisional hernia with an acell surgical graft to reinforce the component separation of the abdominal wall musculature on (b)(6) 2017.Four months post operative, the surgical repair is intact with no recurrence of the hernia.However, patient has persistent fluid accumulating in his subcutaneous space which has required four episodes of fluid drainage with up to a liter of fluid being evacuated 6 to 8 weeks post operative.Fluid was cultured with no growth observed.Patient has survived the treatment of liver metastases and peritoneal metastases from colon cancer.
|