Patient age and weight were not provided.An event date was not provided.This information will be provided in a supplemental report if and when made available.No device information was provided in the legal complaint.This information will be provided in a supplemental report if and when made available.As no device information was provided in the legal complaint, it is unknown what type of device is under complaint.The product code selected (oez) is not confirmed.This information will be provided in a supplemental report if and when made available.As device information was not provided, the correct manufacturer could not be identified.The country selection ((b)(4)) is not confirmed.The model and serial number have not been provided and the udi could not be determined.This information will be provided in a supplemental report if and when made available.As device information was not provided, the correct manufacturer could not be identified.The country selection (germany) is not confirmed.A model number was not provided, so the 510(k) number could not be determined.The serial number was not provided, so it is unknown if the unit has already been returned or not.This information will be provided in a supplemental report if and when made available.The serial number was not provided, so the manufacture date could not be determined.This information will be provided in a supplemental report if and when made available.Sorin group (b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).On july 14, 2016, sorin group (b)(4) was notified of a legal complaint that was filed on june 23, 2016.The complaint identified a single patient injury from (b)(6) hospital.As no additional information regarding the patient or the reason for the complaint was provided, the report could not be connected to a previous complaint received from the facility.The investigation is on-going.A supplemental report will be provided upon receipt of any additional information.
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On july 14, 2016, sorin group (b)(4) was notified of a legal complaint that was filed on june 23, 2016.The complaint identified a single patient injury from (b)(6) hospital.As no additional information regarding the patient or the reason for the complaint was provided, the report could not be connected to a previous complaint received from the facility.
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