Model Number 0531152-51 |
Device Problems
Kinked (1339); Occlusion Within Device (1423); Material Integrity Problem (2978)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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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).Date of event unknown.Summarizing translation: after surgical intervention pain catheter was placed.After some time the catheter kinked/ catheter is too soft and was occluded.Happened many times.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.Device discarded by user.
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Event Description
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(b)(4).Date of event and device code/ batch in particular unknown.The device data submitted in this report has been rebuilt from plausible data based on supplier files and delivery notes.Summarizing translation: after surgical intervention pain catheter was placed.After some time the catheter kinked/ catheter is too soft and was occluded.Happened many times.
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Search Alerts/Recalls
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