Model Number 521156-31C |
Device Problems
Fracture (1260); Material Rupture (1546)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 01/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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Event took place in (b)(6) and has been reported through (b)(4).Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
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Event Description
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(b)(4).Summarizing tentative translation from initial reporter´s narrative: catheter rupture.A 150mm fragment remains with patient.
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Event Description
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(b)(4).Summarizing tentative translation from initial reporter´s narrative: catheter rupture.150mm fragment remains with patient.
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Manufacturer Narrative
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Event took place in (b)(6) and has been reported through (b)(6).Based on risk management and clinical evaluation this file is considered as closed.(b)(4).
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Search Alerts/Recalls
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