(b)(4).In fact, there was patient involvement as the device in question was implanted, but there is no adverse event or other heath consequences for the patient.The inspection performed on the returned product (sn not object of this report) revealed that the labels on the carton box, on the aluminum pouch and inside the aluminum pouch consistently indicate the same serial number.The label (id tag) attached on the cuff of the prosthesis is also consistent with the serial number shown on the external carton box.However, the documents inside the carton box (i.E.Registration form, labels for clinical use, patient card) indicate a different serial number, the same as the one appearing implanted in the patient from the medical records.The device history records (dhr) reviews for both serial numbers involved (the returned device and the implanted device).The results confirmed that both devices satisfied all material, visual and performance standards required at the time of manufacture and release.Further verification of the re-packaging documents indicate that both devices were returned by finished goods warehouse to be repackaged.Considering the evidence of the product returned and the results of the dhr performed, it is possible that during the manual repackaging, the documents inside the cartons could have been inadvertently interchanged.Further investigation is ongoing.
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On (b)(6) 2021, the manufacturer became aware of a product mis-labelling with a livanova device.In particular, a carboseal device model cp-023 was implanted in a patient.However, the serial number of the device that appears in the patient's registration form is not the same as the serial number appearing on the medical records of the hospital.Furthermore, the device model cp-023 with the same serial number showed on the patient's implant card was returned to the manufacturer as expired and not used for any implant.
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