Catalog Number 260815C |
Device Problem
Device Appears to Trigger Rejection (1524)
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Patient Problems
Unspecified Infection (1930); Reaction (2414)
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Event Date 07/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
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Event Description
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It was reported that a patient developed a pinpoint rash to the prep area, blisters, and a ssi.
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Manufacturer Narrative
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No additional information was provided by amanda mccollum (medicine hat regional hospital).Propharma 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 h3 other text : see narrative below.
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Event Description
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It was reported that a patient developed a pinpoint rash to the prep area, blisters, and a ssi.
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Search Alerts/Recalls
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