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Model Number 52969 |
Device Problem
Energy Output Problem (1431)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2016 |
Event Type
Injury
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Manufacturer Narrative
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Report as per request from fda medwatch program."this is to bring to your attention that we are in receipt of several supplement reports submitted by coopersurgical, inc., please be informed that there is no record of initial report submissions in emdr system.It appears that follow-up #1 could be actual initial report but may have been erroneously submitted as follow-up in error.Kindly verify the supplement reports listed below and resubmit follow-up #1 report as initial report electronically through esg webtrader by checking only "initial" box in section g7 and advise when complete.".
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Event Description
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Review of repair order log (b)(6)."inconsistent activation of power current.Pedal switch worked 2-4 x when pressure applied, then ceased.After removal of cord from socket & re-inserted, worked again 2-4 x; then ceased.Repeated this cycle several times with same result ".Reference e-complaint (b)(4).
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Search Alerts/Recalls
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