Model Number 10621-XXXMP |
Device Problems
Fracture (1260); Gel Leak (1267); Patient Device Interaction Problem (4001); Air/Gas in Device (4062)
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Patient Problems
Rupture (2208); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/31/2023 |
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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Bilateral rupture, discovered during surgery, left side; bilateral bubbling, left side and bilateral gel fracture, left side.
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Manufacturer Narrative
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Sientra complaint #: (b)(4).Sientra received the suspected device from the customer and performed a failure analysis.Upon initial observation the device was found to have a shell failure with no discoloration.The device was unable to be weighed.Upon device inspection, there were 4 pinholes found on the anterior side.Upon optical inspection, the explant was received ruptured and was submitted for optical analysis.An area of possible striations was identified.Optical microscope images were taken of the area.The suspected cause of the shell failure is surgical instrument damage.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Manufacturer Narrative
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Sientra complaint #: (b)(4).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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Bilateral rupture, discovered during surgery, left side; bilateral bubbling, left side; bilateral gel fracture, left side and bilateral physical asymmetry, left side.
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Search Alerts/Recalls
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