Model Number 0021351-18 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Fracture (1260); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problems
Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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Event Date 12/18/2016 |
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)(6) distribution subsidiary pajunk medical produkte (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:upon removal of catheter after 2 days (48 hours) catheter ruptured/ broke of.Fragment was left with patient.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.
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Event Description
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(b)(4).Summarizing tentative translation from initial reporter´s narrative:upon removal of catheter after 2 days (48 hours) catheter ruptured/ broke of.Fragment was left with patient.Patient has been informed.
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Search Alerts/Recalls
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