Mw5087059 was reported to medwatch on may 27, 2019.We received it on june 12,2019 and began trying to contact the reporter starting on june 13, 2019.On june 19, 2019, after 2 attempts, we finally spoke with dr (b)(6) who reported that both mw5087039 & mw5087059 medwatch reports were reported by her on the same day.Each report was about a separate incident & she reported them because she "just didn't want to have any hippa violations and that we should really talk to the lab because they are knowledgeable about these things and she was on leave at the time".The dr.Declined to give us any contact information for the lab except the location.We attempted contact with the facility 6 times from 6/18-7/16, 2019.We spoke with several staff members at (b)(6) medical center on july 16, 2019.They were reluctant to give out any information because they did not want to violate hippa regulations.When asked if a patient had been harmed or died they said that they could not answer that.When asked for dates that the incident happened they could not answer that except that it had occurred in the month of (b)(6) 2018.They said they would forward any info they had but did not think they could give us a lot of information because of hippa regulations.We were never contacted by the facility or the doctor to report an incident or to ask for technical support during 2018 or 2019.We received information 7/26/19 suggesting injury to a patient, prompting this report.
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"as the manufacturer, our quality department attempted to contact both the initial reporter and the end user facility about the adverse event.After several attempts, we were able to contact each of them but were not able to gather much information about the incident.Both the initial reporter and the end user facility stated hippa as the reason they would not discuss the adverse event.Subsequent to this, our company was advised through legal counsel that a female patient had a foot or lower left limb amputated.
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