Sales rep.Called on (b)(6) 2014, and reported that the customer had two disposable perforator incidents.Sales rep.Contacted the customer two times, but no other information was provided.On (b)(6) 2014, the sales rep.Called and informed the both disposable perforators failed to disengage and caused damaged to the dura, but they did not go into the brain.Event dates are unknown.Patient's information and condition are unknown.Product codes and lot numbers are unknown.No other information available at this time.Sales rep.Will make another attempt to contact the customer to obtain more information.Also see complaint # (b)(4).
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It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.Device not returned.
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