Model Number 0531152-51 |
Device Problem
Fracture (1260)
|
Patient Problems
Pain (1994); Foreign Body In Patient (2687)
|
Event Date 08/03/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Event took place in (b)(6) and has been reported through (b)(6).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.
|
|
Event Description
|
(b)(4).Catheter torn apart, required intervention to remove fragment.
|
|
Event Description
|
Irn# (b)(4).Catheter torn apart, required intervention to remove fragment.
|
|
Manufacturer Narrative
|
Based on risk assessment and clinical evaluation case is considered as closed.Attachment: [2018-08-18_complaint report for 278-18.Pdf].
|
|
Search Alerts/Recalls
|