As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed. The event cannot be reproduced or substantiated.
Patient Sequence No: 1, Text Type: N, H10
It was reported that patient called to express his dissatisfaction with his artificial urinary sphincter (aus). He states that it worked well initially and then he has started to experience progressive worsening of his incontinence. He states that now it is almost as bad as it was before he had the device. He has been told by his dr. That he needs to have a revision and he is refusing to pay. He doesn't think he should have to pay twice for a device that failed. He is pursuing that with the hospital and dr. Patient liaison explained him that the explanted device would be returned to bsc for analysis.
Patient Sequence No: 1, Text Type: D, B5