The mentor failure analysis lab has received the device for evaluation. The analysis has begun but is not complete at this time. When the investigational analysis has been completed, a supplemental report will be submitted. A manufacturing record evaluation is in progress. Once completed, a supplemental report will be submitted. Reason for device explant and/or reoperation: deflation. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
It was reported that a female patient of an unknown age and ethnicity underwent unspecified breast augmentation with a 550cc mentor tissue expander and experienced unknown side deflation. As a result, the expander was explanted on (b)(6) 2020. Serial number is either (b)(4) if right side effected or (b)(4) if left side is effected. Follow-ups are in progress. Supplemental report will be sent when information is received.
Patient Sequence No: 1, Text Type: D, B5