Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).Pr (b)(4) follow-up emdr for device evaluation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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It was reported that the thora-para non-valved (otp) catheter drainage system was causing the following: re-expansion pulmonary edema, pneumothorax, hemothorax , laceration of lung or lever ,temporary discomfort beyond expected standard of care and, intra-abdominal bleeding following paracentesis.Re-expansion pulmonary edema ¿ 20; pneumothorax - 20 ; hemothorax ¿ 10; laceration of lung or lever ¿ 20; temporary discomfort beyond expected standard of care ¿ 100; intra-abdominal bleeding following paracentesis ¿ 100.No further information provided at time of entry.
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