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Model Number GBF0508 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 09/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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The patient was injected with the product on two different occasions in the same areas: the most recent was with bellafill dermal filler ((b)(4)), lot f151077, in (b)(6) 2015 (exact date unknown).The prior injection was with artefill dermal filler ((b)(4), artefill is the prior brand name), lot f141032, on (b)(6) 2015.Suneva conducted a lot review of a both lots.No issues were found with either lot.The lots were manufactured in accordance with approved work instructions and met acceptance criteria at time of product release.Retained lot samples were also reviewed and the lots continue to meet release criteria.The doctor originally reported nodules on (b)(6) 2016 which were being successfully treated with kenalog, 5fu, and collagenase.The "wood tissue changes" were added by the doctor on (b)(6) 2017.On (b)(6) 2017, the doctor relayed that the "woody tissue changes" were disfiguring and were only improving with multiple treatment injections.The patient was injected in both on-label and off-label locations and had nodules in all areas; however it is not clear at this time where the described "woody tissue changes" were located: on-label: nasolabial folds; off-label: brow, peri-oral areas, and under the eyes.The bellafill injector is aware of bellafill indications.
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Event Description
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Patient ((b)(6)) was injected with bellafill dermal filler (and artefill dermal filler - prior brand name) in the brows, nasolabial folds, peri-oral area, and under the eyes on (b)(6) 2015 and in (b)(6) 2015 (exact date not provided).On (b)(6) 2017 the doctor reported what he described as "woody tissue changes." on (b)(6) 2017, the doctor added that the "woody tissue changes" are disfiguring and are only improving with multiple "dissolving" injections of kenalog, 5fu, and collagenase.
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Search Alerts/Recalls
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