Model Number 37449 |
Device Problems
Failure To Adhere Or Bond (1031); Device Dislodged or Dislocated (2923)
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Patient Problem
Vaginal Mucosa Damage (2124)
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Event Date 10/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Based on the available information, this event is deemed to be a reportable malfunction and a non-serious patient injury.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional details have been requested but not provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).
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Event Description
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Complaint received from a nurse reporting that on two (2) separate incidences when the anchoring device did not adhere well to the skin and caused the catheter to move and tear the urethral mucosal tissue." no further information was provided.
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Manufacturer Narrative
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This supplemental report is being submitted to correct type of reportable event to malfunction which was submitted incorrectly in error for the initial mdr (mfr report# 1000317571-2016-00092) on november 22, 2016.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).
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Search Alerts/Recalls
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