#Natus otometrics serial number#

In the moment the headset was being adjusted on the patient, the headband broke and hit the patient in the head. The headset was has broken during a test with a patient. If action reported to fda under 21 usc 360i (f), list correction / removal reporting number - this section is not applicable as there was no action reported under 21usc 360i(f). If remedial action initiated, check type - this section is not applicable as no remedial action was initiated.

#Natus otometrics serial number#

Manufacture date -this information is unknown as no serial number or lot number provided. If nd, give protocol # - this section is not applicable as the medical device is not ind.ДЄdverse event terms - this section is not applicable to medical devices. Reprocessor name and address - this section is not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient.Д¬oncomitant medical products and therapy dates (excluding treatment of event) - this section is not applicable to this type of device.ДЇor use by user facility / importer - not applicable as we are not a facility or importer of device.ДҐ10k - this product was exempt from 510k. If explanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. If implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. Udi - this is an accessory part and does not have a udi.Д®xpiration date - this information is unknown as no serial number or lot number provided. Serial # - this section is not applicable as the medical device does not have a lot number. Lot # - this section is not applicable as the medical device does not have a lot number. Patient information - information on the ethnicity of the patient is unknown. No further investigation can be completed on the defective product as the headset has been discarded by the customer.