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. Related components of device system: model number/ catalog number: 72404127, serial number: n/a, batch/ lot number: 0147811018. Model/ catalog description: control pump fgs iz. Model number/ catalog number: 72400024, serial number: n/a, batch/ lot number: 0147781017, model/ catalog description: balloon fgs 61-70 cm.
Patient Sequence No: 1, Text Type: N, H10
It was reported that the patient experienced recurring incontinence due to urethral atrophy at the cuff site of his artificial urinary sphincter (aus). All components were removed and replaced with a new aus system. The patient had a good outcome with no further complication. Additional information received. The explanted 3. 5 cm cuff was replaced with a 4. 5 cm cuff. The previous cuff was the correct size and was placed in the correct location.
Patient Sequence No: 1, Text Type: D, B5