A patient experienced a small seroma, pain, redness, not feeling well and itching after undergoing a surgical procedure in which veritas was used.The patient had undergone a bilateral breast reconstruction surgery where tissue expanders were removed and replaced with allergan implants and veritas.Six weeks post operatively (post-op) the patient developed a small seroma and was not feeling well.One week later, the patient experienced pain, inflammation, redness and itching to the whole breast area.As a result, the implants and the veritas were surgically removed.No further detail was provided regarding any further medical intervention or regarding the patient¿s outcome from the event.No additional information is available.
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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