The clip was applied on (b)(6) 2019.On (b)(6) 2019, the patient was at a check-up appointment, when no abnormalies were detected.Thus, the clip was in the patient's body for 1 month without any irritation being detected.Furthermore, the patient never did an allergy test to prove that she is allergic to nickel.It is also not clear, what caused the abscess.Arising from this information, it is questionable, whether the event could be a reaction to the clip at all.It is stated in the instruction for use that the clip is made of a nickel titanium alloy.Furthermore, the following contraindication is defined in the instruction for use: "the use of the tumark vision system is contraindicated in patients who suffer from a severe nickel allergy." in case that the patient is really allergic to nickel, the contraindication was not considered by the doctor.The doctor states, that the clip marker may not be responsible for the abscess and that a proof for the dependency between the marker and the abscess is hardly to deliver.She assumes that, arising from the skin irritation in combination with the chemotherapy, the patient definitely scratched herself very often, and hence, the patient may have fostered the developement of the abscess by herself.
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