A comprehensive investigation was conducted on discovery.At the time of this report, acell did not receive lot numbers for the devices in question.However, since it was reported that the procedures were performed in (b)(6) 2015, batch records for all possible products used by the physician in (b)(6) 2015 were reviewed.A review of the manufacturing records for these lots identified no substantial deviations and purport the products were manufactured and distributed sterile in compliance with fda, state, local, and manufacturer operating procedures.There were no reports of device failure at the time of surgery.Tests of sister grafts from the identified lots met specifications.This mdr has been filed out of an abundance of caution.
|