Model Number 021151-29A |
Device Problems
Break (1069); Crack (1135); Fracture (1260); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
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Patient Problems
Pain (1994); Inadequate Pain Relief (2388)
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Event Date 09/15/2016 |
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) distribution subsidiary (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: spinal needle broke upon removal.
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Manufacturer Narrative
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(b)(4).Based on risk assessment and clinical evaluation file is considered as closed.Device not returned.
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Event Description
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(b)(4).Summarizing tentative translation from initial reporter´s narrative: spinal needle broke upon removal.
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Search Alerts/Recalls
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