As reported by the ous rep, when a lumbar catheter was withdrawn by the surgeon, the catheter tore, leaving 15 cm in the patient's back.Patient is stable; a lumbar spine ct scan was requested and testing is pending.
|
It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were not successful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
|