(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No additional information was provided by the (b)(6).Primevigilance did reach out to obtain with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.All complaints are reviewed during monthly quality/safety meetings.In addition, complaints are trended at monthly quality data analyst meetings and quarterly plant management review meetings.
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It was reported that a patient developed an infection during a study where chlorhexidine was used.Per literature: patients undergoing elective primary total knee and hip replacement surgery between (b)(6) 2016 and (b)(6) 2020 were included.Three orthopedists recruited patients who agreed to participate in the study and provided written informed consent.Each of the four cephalosporin-containing regimens was sequentially administered to consecutively enrolled patients; penicillin-allergic patients received vancomycin or vancomycin and gentamicin.Preoperative whole-body bathing or showering with chlorhexidine soap antibiotics 2021, 10, 18 3 of 14 on the day of the surgical procedure and the night before was indicated.Alcoholic 2% chlorhexidine was used as antiseptic for skin preparation before surgical incision.A minimum follow-up of one year was planned after prosthesis implantation in order.
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