PFM Medical TiLOOP Bra Notice D'utilisation page 15

Material information
Tab. 01: Overview of the materials
Mesh implant materials
titanium containing coating
polypropylene
The titanized mesh implant does not contain diethylhexylphthalate (DEHP).
Disposal
All of the components that are supplied with the product and any mesh implants that are not used,
mesh blanks and explants are to be handled and disposed of safely conform with standard hospital
rules and national and regional laws and regulations. Components that are supplied together with the
product could be packaging and instructions for use, for example. Special attention is to be paid to the
special hazardous waste requirements in the case of infectious waste.
Miscellaneous
• The patient is to be informed of the warnings, precautions, contraindications and possible com-
plications that concern her.
• The patient is to be issued with the patient information leaflet and the completed implant card.
• The link to the summary of safety and clinical performance (SSCP = summary of safety and clinical
performance) shall be made available as soon as the European database on medical devices (Euda-
med = European database on medical devices) has been completed.
• All serious events that occur in connection with the product are to be reported to the manufactu-
rer and the responsible national authority.
MK-E000689_10 / 2022-01-28
Material shares
that the patient comes into contact with
mainly
slightly
(e.g. when the mesh implant is cut to size)
English
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