Model Number 10621-XXXHP |
Device Problems
Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
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Patient Problems
Capsular Contracture (1761); Breast Discomfort/Pain (4504); Swelling/ Edema (4577)
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Event Date 07/10/2023 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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Left-side capsular contracture, baker grade unknown and patient claim breast implant illness, symptoms: breast pain, swelling.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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