According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.
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On (b)(6) 2023, the patient underwent kidney puncture and drainage under b-ultrasound guidance due to hydronephrosis.After the doctor placed the tube successfully that day, he found that there was a crack at the interface of the drainage tube, which was covered by other parts before operation and could not be tested.The doctor immediately strengthened the fixation with adhesive tape for remedy, but there was a risk of increasing infection, and immediately reported adverse events.
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