Model Number 121151-27A |
Device Problem
Fracture (1260)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 01/22/2019 |
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) distribution subsidiary pajunk medical produkte (b)(4).Currently the data is poor and the device has not been returned/ 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).Tentative translation from initial reporter´s narrative: sectio, unable to gain access to spinal space l3/l4, upon removal of the needle without stylet 40mm from the distal end are missing.
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Manufacturer Narrative
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Event took place in germany and has been reported through german distribution subsidiary pajunk medical produkte gmbh.Based on risk assessment and clinical evaluation file this case is considered as closed.
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Event Description
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Irn# 609_039-18.Tentative translation from initial reporter´s narrative: sectio, unable to gain access to spinal space l3/l4, upon removal of the needle without stylet 40mm from the distal end are missing.
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Search Alerts/Recalls
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