Patient implant info
Middle ear prosthesis (OCR - Ossicular Chain Replacement prosthesis)
Warnings, precautions or measures to be taken by the patient or a healthcare professional in relation to mutual interference with reasonably foreseeable external influences, medical examinations or environmental conditions:
The medical device is sterile and it is destined to be implanted in humans. It can be made, depending on device type, by: titanium, platinum, teflon, nitinol, hydroxyapatite. In the period following the implant, baro-traumas (diving, snorkeling) must be avoided and the risk of head trauma must be minimized, in order to reduce the risk of dislocation of the prosthesis.
Information on the expected useful life of the device and on any necessary follow-up:
The device remains implanted for the whole patient's life-time. At clinician's choice, consultations and post-surgery follow-up might be required.
Any other information required to ensure safe use of the device by the patient, including the information referred to in Annex I, point 23.4, letter u): "in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients may be exposed:"
Do not use auricolar swabs. In case of auricolar washing, warn the doctor that you're carrying a middle ear implant.
ADM for senology
Warnings, precautions or measures to be taken by the patient or a healthcare professional in relation to mutual interference with reasonably foreseeable external influences, medical examinations or environmental conditions:
The medical device is sterile and intended for human implantation. It is composed of collagen of animal origin completely similar to that of humans: in stable contact with the patient's healthy tissues, the device is re-proposed by the cells and transformed into the patient's own tissue in about 6 months with a regenerative process. In the period preceding its transformation into tissue, the device is identifiable by ultrasound examination. Beyond these, there are no special considerations or precautions that the patient or healthcare professional should take in connection with the implantation of this device.
Information on the expected useful life of the device and on any necessary follow-up:
The device, transforming itself into the patient's tissue, requires follow-up only for the duration of the regenerative process. Subsequently, visits or examinations may make it necessary for the follow-up of any primary application or to check other devices possibly implanted complementarity to this, for which we refer to the respective manufacturers.
Any other information required to ensure safe use of the device by the patient, including the information referred to in Annex I, point 23.4, letter u): "in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients may be exposed; "
The device is composed of collagen derived entirely from porcine dermis / equine pericardium and its use is contraindicated in patients allergic or hypersensitive to materials of porcine / equine origin. Once implanted, the device can be identified by itself in the implantation site for the time necessary for its transformation into the patient's own tissue through the natural exchange / turnover of collagen (approximately 6 months).