Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 09/21/2015 |
Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.This report is for unk - pins/wires/unknown lot number.Explant date: not explanted.Device is not expected to be returned for manufacturer review/investigation.Pma 510k#: unknown.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that during a procedure on (b)(6) 2015 a guide wire broke inside of the patient.There is no reported patient harm.This report is 1 of 1 for (b)(4).
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Manufacturer Narrative
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This was a duplicate mw, retraction submitted.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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This medwatch is being rescinded.The complaint was reviewed on (b)(4) 2015 and event does not meet the definition of an mdr reportable event because this complaint is a duplicate of (b)(4) and will be rescinded.
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Search Alerts/Recalls
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