Device Problems
Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
|
Patient Problems
Breast Cancer (1759); Capsular Contracture (1761)
|
Event Date 06/14/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Sientra complaint #: (b)(4).At this time, the suspect device has not been returned for evaluation.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
|
|
Event Description
|
Bilateral capsular contracture, baker grade 4, left side and left-side inflammatory breast cancer.
|
|
Manufacturer Narrative
|
Sientra complaint #: (b)(4).Sientra was unable to perform an evaluation as the device was discarded by the customer.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device discarded.
|
|
Search Alerts/Recalls
|