Model Number 20621-XXXMP |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Fatigue (1849); Muscle Weakness (1967); Twitching (2172); Neck Pain (2433); Cognitive Changes (2551); Breast Discomfort/Pain (4504); Cramp(s) /Muscle Spasm(s) (4521)
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Event Date 12/19/2023 |
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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Patient claim breast implant illness, symptoms: muscle spasms, muscle twitching, atrophy in shoulder, neck pain, brain fog, memory issues, severe fatigue, right-side breast pain.There isn¿t an official medical diagnosis for breast implant illness.
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Manufacturer Narrative
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Sientra complaint #: (b)(4).Device evaluation: d9, g3, g6, h2, h3, h6, h10.Sientra received the suspected device from the customer and performed a failure analysis.The device was returned intact and functional with light yellowing.The device weighed 307.3 grams.No additional observations.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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