Model Number 121251-30A |
Device Problems
Detachment Of Device Component (1104); Entrapment of Device (1212); Detachment of Device or Device Component (2907)
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Patient Problems
No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
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Event Date 03/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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.Event took place in (b)(6) and has been reported through (b)(4) distributor (b)(4).
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Event Description
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(b)(4).From initial reporter´s narrative: when using the product the injection plastic part on the needle suddenly falls of.Parts of the needle was still in the patient's back.The doctor could get the needle without harming the patient.
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Event Description
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Irn# 560_155-18.From initial reporter´s narrative: when using the product the injection plastic part on the needle suddently falls of.Parts of the needle was still in the patiens back.The doctor could get the needle without harming the patient.
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Manufacturer Narrative
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Based on risk management assessment and clinical evaluation report this file is considered as closed.- attachment: [2018-09-20_560_155-18_9611612-2018-00024fu_report.Pdf].
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Search Alerts/Recalls
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